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1.
J Appl Clin Med Phys ; 16(5): 14­34, 2015 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-26699330

RESUMO

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines:• Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline.• Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.


Assuntos
Elétrons , Física Médica/normas , Fótons , Neoplasias da Próstata/radioterapia , Garantia da Qualidade dos Cuidados de Saúde/normas , Radioterapia (Especialidade)/normas , Planejamento da Radioterapia Assistida por Computador/normas , Humanos , Masculino , Guias de Prática Clínica como Assunto , Dosagem Radioterapêutica , Estados Unidos
2.
Med Phys ; 2024 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-39073127

RESUMO

Incident reporting and learning systems provide an opportunity to identify systemic vulnerabilities that contribute to incidents and potentially degrade quality. The narrative of an incident is intended to provide a clear, easy to understand description of an incident. Unclear, incomplete or poorly organized narratives compromise the ability to learn from them. This report provides guidance for drafting effective narratives, with particular attention to the use of narratives in incident reporting and learning systems (IRLS). Examples are given that compare effective and less than effective narratives. This report is mostly directed to organizations that maintain IRLS, but also may be helpful for individuals who desire to write a useful narrative for entry into such a system. Recommendations include the following: (1) Systems should allow a one- or two-sentence, free-text synopsis of an incident without guessing at causes; (2) Information included should form a sequence of events with chronology; and (3) Reporting and learning systems should consider using the headings suggested to guide the reporter through the narrative: (a) incident occurrences and actions by role; (b) prior circumstances and actions; (c) method by which the incident was identified; (d) equipment related details if relevant; (e) recovery actions by role; (f) relevant time span between responses; (g) and how individuals affected during or immediately after incident. When possible and appropriate, supplementary information including relevant data elements should be included using numerical scales or drop-down choices outside of the narrative. Information that should not be included in the narrative includes: (a) patient health information (PHI); (b) conjecture or blame; (c) jargon abbreviations or details without specifying their significance; (d) causal analysis.

3.
Med Phys ; 39(5): 2904-29, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22559663

RESUMO

PURPOSE: Recommendations of the American Association of Physicists in Medicine (AAPM) and the European Society for Radiotherapy and Oncology (ESTRO) on dose calculations for high-energy (average energy higher than 50 keV) photon-emitting brachytherapy sources are presented, including the physical characteristics of specific (192)Ir, (137)Cs, and (60)Co source models. METHODS: This report has been prepared by the High Energy Brachytherapy Source Dosimetry (HEBD) Working Group. This report includes considerations in the application of the TG-43U1 formalism to high-energy photon-emitting sources with particular attention to phantom size effects, interpolation accuracy dependence on dose calculation grid size, and dosimetry parameter dependence on source active length. RESULTS: Consensus datasets for commercially available high-energy photon sources are provided, along with recommended methods for evaluating these datasets. Recommendations on dosimetry characterization methods, mainly using experimental procedures and Monte Carlo, are established and discussed. Also included are methodological recommendations on detector choice, detector energy response characterization and phantom materials, and measurement specification methodology. Uncertainty analyses are discussed and recommendations for high-energy sources without consensus datasets are given. CONCLUSIONS: Recommended consensus datasets for high-energy sources have been derived for sources that were commercially available as of January 2010. Data are presented according to the AAPM TG-43U1 formalism, with modified interpolation and extrapolation techniques of the AAPM TG-43U1S1 report for the 2D anisotropy function and radial dose function.


Assuntos
Braquiterapia/métodos , Fótons/uso terapêutico , Doses de Radiação , Relatório de Pesquisa , Sociedades Médicas , Anisotropia , Humanos , Método de Monte Carlo , Imagens de Fantasmas , Radioisótopos/uso terapêutico , Radiometria , Dosagem Radioterapêutica
4.
Am J Clin Oncol ; 45(6): 243-248, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35485607

RESUMO

AIM/OBJECTIVES/BACKGROUND: The American College of Radiology (ACR), the American Brachytherapy Society (ABS), and the American Society for Radiation Oncology (ASTRO) have jointly developed the following practice parameter for the performance of low-dose-rate (LDR) brachytherapy. LDR brachytherapy is the application of radioactive sources in or on tumors in a clinical setting with therapeutic intent. The advantages of LDR brachytherapy include improving therapeutic ratios with lower doses to nontarget organs-at-risk and higher doses to a specific target. METHODS: This practice parameter was developed according to the process described under the heading. The Process for Developing ACR Practice Parameters and Technical Standards on the ACR website (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters-Radiation Oncology of the Commission on Radiation Oncology, in collaboration with ABS and ASTRO. RESULTS: This practice parameter was developed to serve as a tool in the appropriate application of this evolving technology in the care of cancer patients or other patients with conditions where radiation therapy is indicated. It addresses clinical implementation of LDR brachytherapy including personnel qualifications, quality assurance standards, indications, and suggested documentation. This includes a contemporary literature search. CONCLUSIONS: This practice parameter is a tool to guide the use of LDR brachytherapy and does not assess relative clinical indication for LDR brachytherapy when compared with other forms of brachytherapy or external beam therapy, but to focus on the best practices required to deliver LDR brachytherapy safely and effectively, when clinically indicated. Comparative costs of versus other modalities therapy may also need to be considered.


Assuntos
Braquiterapia , Neoplasias , Radioterapia (Especialidade) , Humanos , Neoplasias/radioterapia , Dosagem Radioterapêutica , Sociedades Médicas , Estados Unidos
5.
Am J Clin Oncol ; 45(6): 249-257, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35588224

RESUMO

AIM/OBJECTIVES/BACKGROUND: The American College of Radiology (ACR), American Brachytherapy Society (ABS), and American Society for Radiation Oncology (ASTRO) have jointly developed the following practice parameter for transperineal permanent brachytherapy of prostate cancer. Transperineal permanent brachytherapy of prostate cancer is the interstitial implantation of low-dose rate radioactive seeds into the prostate gland for the purpose of treating localized prostate cancer. METHODS: This practice parameter was developed according to the process described under the heading The Process for Developing ACR Practice Parameters and Technical Standards on the ACR website (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters-Radiation Oncology of the Commission on Radiation Oncology, in collaboration with ABS and ASTRO. RESULTS: This practice parameter provides a framework for the appropriate use of low-dose rate brachytherapy in the treatment of prostate cancer either as monotherapy or as part of a treatment regimen combined with external-beam radiation therapy. The practice parameter defines the qualifications and responsibilities of all involved radiation oncology personnel, including the radiation oncologist, medical physicist, dosimetrist, radiation therapist, and nursing staff. Patient selection criteria and the utilization of supplemental therapies such as external-beam radiation therapy and androgen deprivation therapy are discussed. The logistics of the implant procedure, postimplant dosimetry assessment, and best practices with regard to safety and quality control are presented. CONCLUSIONS: Adherence to established standards can help to ensure that permanent prostate brachytherapy is delivered in a safe and efficacious manner.


Assuntos
Braquiterapia , Neoplasias da Próstata , Radioterapia (Especialidade) , Antagonistas de Androgênios , Braquiterapia/métodos , Humanos , Masculino , Seleção de Pacientes , Neoplasias da Próstata/radioterapia
6.
Brachytherapy ; 20(3): 497-511, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33824051

RESUMO

PURPOSE: The American College of Radiology (ACR), American Brachytherapy Society (ABS), American College of Nuclear Medicine (ACNM), American Society for Radiation Oncology (ASTRO), Society of Interventional Radiology (SIR), and Society of Nuclear Medicine and Molecular Imaging (SNMMI) have jointly developed a practice parameter on selective internal radiation therapy (SIRT) or radioembolization for treatment of liver malignancies. Radioembolization is the embolization of the hepatic arterial supply of hepatic primary tumors or metastases with a microsphere yttrium-90 brachytherapy device. MATERIALS AND METHODS: The ACR -ABS -ACNM -ASTRO -SIR -SNMMI practice parameter for SIRT or radioembolization for treatment of liver malignancies was revised in accordance with the process described on the ACR website (https://www.acr.org/ClinicalResources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters-Interventional and Cardiovascular Radiology of the ACR Commission on Interventional and Cardiovascular, Committee on Practice Parameters and Technical Standards-Nuclear Medicine and Molecular Imaging of the ACR Commission on Nuclear Medicine and Molecular Imaging and the Committee on Practice Parameters-Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with ABS, ACNM, ASTRO, SIR, and SNMMI. RESULTS: This practice parameter is developed to serve as a tool in the appropriate application of radioembolization in the care of patients with conditions where indicated. It addresses clinical implementation of radioembolization including personnel qualifications, quality assurance standards, indications, and suggested documentation. CONCLUSIONS: This practice parameter is a tool to guide clinical use of radioembolization. It focuses on the best practices and principles to consider when using radioemboliozation effectively. The clinical benefit and medical necessity of the treatment should be tailored to each individual patient.


Assuntos
Braquiterapia , Neoplasias Hepáticas , Medicina Nuclear , Radioterapia (Especialidade) , Braquiterapia/métodos , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/radioterapia , Imagem Molecular , Radioisótopos de Ítrio/uso terapêutico
7.
Med Phys ; 37(5): 2300-11, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20527564

RESUMO

Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use can be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).


Assuntos
Comitês Consultivos , Equipamentos e Provisões , Uso Off-Label/legislação & jurisprudência , Radioterapia/instrumentação , Sociedades Científicas , United States Food and Drug Administration/legislação & jurisprudência , Braquiterapia/instrumentação , Humanos , Responsabilidade Legal , Microesferas , Neoplasias/terapia , Uso Off-Label/estatística & dados numéricos , Mecanismo de Reembolso/legislação & jurisprudência , Estados Unidos
8.
Brachytherapy ; 19(6): 874-880, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32950407

RESUMO

Developing any new radiation oncology program requires planning and analysis of the current state of the facility and its capacity to take on another program. Staff must consider a large number of factors to establish a feasible, safe, and sustainable program. We present a simple and generic outline that lays out the process for developing and implementing a new HDR brachytherapy program in any setting, but with particular emphasis on challenges associated with starting the program in a limited resource setting. The sections include feasibility of a program, starting cases, machine and equipment selection, and quality and safety.


Assuntos
Braquiterapia , Desenvolvimento de Programas/métodos , Radioterapia (Especialidade)/organização & administração , Braquiterapia/efeitos adversos , Braquiterapia/instrumentação , Braquiterapia/métodos , Braquiterapia/normas , Humanos , Garantia da Qualidade dos Cuidados de Saúde , Radioterapia (Especialidade)/educação , Dosagem Radioterapêutica , Gestão da Segurança
9.
Brachytherapy ; 19(6): 820-826, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32928682

RESUMO

The American Brachytherapy Society brachytherapy schools have been pivotal in teaching and evolving the art of brachytherapy over the past decades. Founded in 1995, the schools have consistently provided content for the major disease sites including gynecologic, prostate, and breast with ocular, vascular, head and neck, pediatric, intraluminal, systemic, and intraoperative approaches more selectively addressed. In addition, Physics schools, either coupled with clinical schools or as stand-alone venues, have provided an essential educational component for practicing physicists, a pivotal part of the brachytherapy team. Celebrating 25 years in existence, this historical overview of the American Brachytherapy Society brachytherapy schools is a tribute to the many teachers who have shared their expertise, to the many students who have been enthusiastic and interactive participants, and the staff who have made it all possible, with the reward of perpetuating the important and timely art of brachytherapy.


Assuntos
Braquiterapia , Física/educação , Radioterapia (Especialidade)/educação , Instituições Acadêmicas/história , Sociedades Médicas/história , História do Século XX , História do Século XXI , Humanos , Estados Unidos
10.
Brachytherapy ; 19(6): 762-766, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32952055

RESUMO

PURPOSE: Safe delivery of brachytherapy and establishing a safety culture are critical in high-quality brachytherapy. The American Brachytherapy Society (ABS) Quality and Safety Committee surveyed members regarding brachytherapy services offered, safety practices during treatment, quality assurance procedures, and needs to develop safety and training materials. METHODS AND MATERIALS: A 22-item survey was sent to ABS membership in early 2019 to physicians, physicists, therapists, nurses, and administrators. Participation was voluntary. Responses were summarized with descriptive statistics and relative frequency distributions. RESULTS: There were 103 unique responses. Approximately one in three was attending physicians and one in three attending physicists. Most were in practice >10 years. A total of 94% and 50% performed gynecologic and prostate brachytherapy, respectively. Ninety-one percent performed two-identification patient verification before treatment. Eighty-six percent performed a time-out. Ninety-five percent had an incident reporting or learning system, but only 71% regularly reviewed incidents. Half reviewed safety practices within the last year. Twenty percent reported they were somewhat or not satisfied with department safety culture, but 92% of respondents were interested in improving safety culture. Most reported time, communication, and staffing as barriers to improving safety. Most respondents desired safety-oriented webinars, self-assessment modules, learning modules, or checklists endorsed by the ABS to improve safety practice. CONCLUSIONS: Most but not all practices use standards and quality assurance procedures in line with society recommendations. There is a need to heighten safety culture at many departments and to shift resources (e.g., time or staffing) to improve safety practice. There is a desire for society guidance to improve brachytherapy safety practices. This is the first survey to assess safety practice patterns among a national sample of radiation oncologists with expertise in brachytherapy.


Assuntos
Braquiterapia/estatística & dados numéricos , Neoplasias dos Genitais Femininos/radioterapia , Segurança do Paciente , Neoplasias da Próstata/radioterapia , Garantia da Qualidade dos Cuidados de Saúde/estatística & dados numéricos , Radioterapia (Especialidade)/organização & administração , Braquiterapia/efeitos adversos , Braquiterapia/normas , Lista de Checagem , Comunicação , Feminino , Humanos , Masculino , Cultura Organizacional , Sistemas de Identificação de Pacientes/estatística & dados numéricos , Admissão e Escalonamento de Pessoal , Melhoria de Qualidade , Gestão de Riscos/estatística & dados numéricos , Inquéritos e Questionários , Fatores de Tempo
11.
Med Phys ; 47(8): e913-e919, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32246456

RESUMO

The purpose of this report is to provide detailed guidance on the dosimetry of the INTRABEAM® (Carl Zeiss Medical AG, Jena, Germany) electronic brachytherapy (eBT) system as it stands at the present time. This report has been developed by the members of American Association of Physicists in Medicine (AAPM) Task Group 292 and endorsed by the AAPM. Members of AAPM Task Group 292 on Electronic-Brachytherapy Dosimetry have reviewed pertinent publications and user manuals regarding the INTRABEAM system dosimetry and manufacturer-supplied dose calculation protocols. Formal written correspondence with Zeiss has also provided further clarification. Dose-rate calculations for the INTRABEAM system are highly dependent on choice of dosimetry protocol. Even with careful protocol selection, large uncertainties remain due to the incomplete characterization of the ionization chambers used for verification with respect to their energy dependence as well as manufacturing variations. There are two distinct sets of dose-rate data provided by Zeiss for the INTRABEAM system. One dataset (Calibration V4.0) is representative of the physical dose surrounding the source and the other dataset (TARGIT) has been adjusted to be consistent with a clinical trial named TARGIT (TARGeted Intraoperative RadioTherapy). The adjusted TARGIT doses are quite dissimilar to the physical doses, with differences ranging from 14% to 30% at the surface of a spherical applicator, depending on its diameter, and up to a factor of two at closer distances with the smaller needle applicators. In addition, ion chamber selection and associated manufacturing tolerances contribute to significant additional uncertainties. With these substantial differences in dose rates and their associated uncertainties, it is important for users to be aware of how each value is calculated and whether it is appropriate to be used for the intended treatment. If users intend to deliver doses that are the same as they were in 1998 at the onset of the TARGIT trial, then the TARGIT dose-rate tables should be used. The Calibration V4.0 dose rates may be more appropriate to use for applications other than TARGIT trial treatments, since they more closely represent the physical doses being delivered. Users should also be aware of the substantial uncertainties associated with the provided dose rates, which are due to beam hardening, chamber geometry, and selection of the point-of-measurement for a given ionization chamber. This report serves to describe the details and implications of the manufacturer-recommended dosimetry formalism for users of the INTRABEAM system.


Assuntos
Braquiterapia , Calibragem , Eletrônica , Alemanha , Radiometria , Dosagem Radioterapêutica , Estados Unidos
12.
Brachytherapy ; 19(4): 415-426, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32409128

RESUMO

PURPOSE: Keratinocyte carcinoma (KC, previously nonmelanoma skin cancer) represents the most common cancer worldwide. While surgical treatment is commonly utilized, various radiation therapy techniques are available including external beam and brachytherapy. As such, the American Brachytherapy Society has created an updated consensus statement regarding the use of brachytherapy in the treatment of KCs. METHODS: Physicians and physicists with expertise in skin cancer and brachytherapy created a consensus statement for appropriate patient selection, data, dosimetry, and utilization of skin brachytherapy and techniques based on a literature search and clinical experience. RESULTS: Guidelines for patient selection, evaluation, and dose/fractionation schedules to optimize outcomes for patients with KC undergoing brachytherapy are presented. Studies of electronic brachytherapy are emerging, although limited long-term data or comparative data are available. Radionuclide-based brachytherapy represents an appropriate option for patients with small KCs with multiple techniques available. CONCLUSIONS: Skin brachytherapy represents a standard of care option for appropriately selected patients with KC. Radionuclide-based brachytherapy represents a well-established technique; however, the current recommendation is that electronic brachytherapy be used for KC on prospective clinical trial or registry because of a paucity of mature data.


Assuntos
Braquiterapia/normas , Carcinoma Basocelular/radioterapia , Carcinoma de Células Escamosas/radioterapia , Neoplasias Cutâneas/radioterapia , Braquiterapia/métodos , Consenso , Fracionamento da Dose de Radiação , Humanos , Seleção de Pacientes , Radioisótopos/uso terapêutico , Estados Unidos
13.
Med Phys ; 47(10): e951-e987, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32862452

RESUMO

The surface brachytherapy Task Group report number 253 discusses the common treatment modalities and applicators typically used to treat lesions on the body surface. Details of commissioning and calibration of the applicators and systems are discussed and examples are given for a risk-based analysis approach to the quality assurance measures that are necessary to consider when establishing a surface brachytherapy program.


Assuntos
Braquiterapia , Calibragem , Dosagem Radioterapêutica , Relatório de Pesquisa
14.
Med Phys ; 47(4): e65-e91, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31702063

RESUMO

PURPOSE: The purpose of this study was to provide guidance on quality management for electronic brachytherapy. MATERIALS AND METHODS: The task group used the risk-assessment approach of Task Group 100 of the American Association of Physicists in Medicine. Because the quality management program for a device is intimately tied to the procedure in which it is used, the task group first designed quality interventions for intracavitary brachytherapy for both commercial electronic brachytherapy units in the setting of accelerated partial-breast irradiation. To demonstrate the methodology to extend an existing risk analysis for a different application, the task group modified the analysis for the case of post-hysterectomy, vaginal cuff irradiation for one of the devices. RESULTS: The analysis illustrated how the TG-100 methodology can lead to interventions to reduce risks and improve quality for each unit and procedure addressed. CONCLUSION: This report provides a model to guide facilities establishing a quality management program for electronic brachytherapy.


Assuntos
Braquiterapia/instrumentação , Equipamentos e Provisões Elétricas , Relatório de Pesquisa , Sociedades Médicas , Controle de Qualidade , Medição de Risco , Fluxo de Trabalho
15.
Brachytherapy ; 16(6): 1083-1090, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28988661

RESUMO

BACKGROUND: This collaborative practice parameter technical standard has been created between the American College of Radiology and American Brachytherapy Society to guide the usage of electronically generated low energy radiation sources (ELSs). It refers to the use of electronic X-ray sources with peak voltages up to 120 kVp to deliver therapeutic radiation therapy. MAIN FINDINGS: The parameter provides a guideline for utilizing ELS, including patient selection and consent, treatment planning, and delivery processes. The parameter reviews the published clinical data with regard to ELS results in skin, breast, and other cancers. CONCLUSIONS: This technical standard recommends appropriate qualifications of the involved personnel. The parameter reviews the technical issues relating to equipment specifications as well as patient and personnel safety. Regarding suggestions for educational programs with regard to this parameter,it is suggested that the training level for clinicians be equivalent to that for other radiation therapies. It also suggests that ELS must be done using the same standards of quality and safety as those in place for other forms of radiation therapy.


Assuntos
Radioterapia/instrumentação , Radioterapia/normas , Braquiterapia/instrumentação , Braquiterapia/métodos , Braquiterapia/normas , Neoplasias da Mama/radioterapia , Feminino , Humanos , Oncologia/educação , Neoplasias/radioterapia , Segurança do Paciente , Seleção de Pacientes , Radioterapia/métodos , Planejamento da Radioterapia Assistida por Computador/métodos , Planejamento da Radioterapia Assistida por Computador/normas , Neoplasias Cutâneas/radioterapia , Sociedades Médicas , Estados Unidos
16.
J Contemp Brachytherapy ; 8(5): 441-447, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27895687

RESUMO

The Valencia applicators (Nucletron, an Elekta company, Elekta AB, Stockholm, Sweden) are cup-shaped tungsten applicators with a flattening filter used to collimate the radiation produced by a high-dose-rate (HDR) 192Ir source, and provide a homogeneous absorbed dose at a given depth. This beam quality provides a good option for the treatment of skin lesions at shallow depth (3-4 mm). The user must perform commissioning and periodic testing of these applicators to guarantee the proper and safe delivery of the intended absorbed dose, as recommended in the standards in radiation oncology. In this study, based on AAPM and GEC-ESTRO guidelines for brachytherapy units and our experience, a set of tests for the commissioning and periodic testing of the Valencia applicators is proposed. These include general considerations, verification of the manufacturer documentation and physical integrity, evaluation of the source-to-indexer distance and reproducibility, setting the library plan in the treatment planning system, evaluation of flatness and symmetry, absolute output and percentage depth dose verification, independent calculation of the treatment time, and visual inspection of the applicator before each treatment. For each test, the proposed methodology, equipment, frequency, expected results, and tolerance levels (when applicable) are provided.

17.
J Contemp Brachytherapy ; 8(6): 518-524, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28115958

RESUMO

PURPOSE: Esteya® (Nucletron, an Elekta company, Elekta AB, Stockholm, Sweden) is an electronic brachytherapy device used for skin cancer lesion treatment. In order to establish an adequate level of quality of treatment, a risk analysis of the Esteya treatment process has been done, following the methodology proposed by the TG-100 guidelines of the American Association of Physicists in Medicine (AAPM). MATERIAL AND METHODS: A multidisciplinary team familiar with the treatment process was formed. This team developed a process map (PM) outlining the stages, through which a patient passed when subjected to the Esteya treatment. They identified potential failure modes (FM) and each individual FM was assessed for the severity (S), frequency of occurrence (O), and lack of detection (D). A list of existing quality management tools was developed and the FMs were consensually reevaluated. Finally, the FMs were ranked according to their risk priority number (RPN) and their S. RESULTS: 146 FMs were identified, 106 of which had RPN ≥ 50 and 30 had S ≥ 7. After introducing the quality management tools, only 21 FMs had RPN ≥ 50. The importance of ensuring contact between the applicator and the surface of the patient's skin was emphasized, so the setup was reviewed by a second individual before each treatment session with periodic quality control to ensure stability of the applicator pressure. Some of the essential quality management tools are already being implemented in the installation are the simple templates for reproducible positioning of skin applicators, that help marking the treatment area and positioning of X-ray tube. CONCLUSIONS: New quality management tools have been established as a result of the application of the failure modes and effects analysis (FMEA) treatment. However, periodic update of the FMEA process is necessary, since clinical experience has suggested occurring of further new possible potential failure modes.

18.
Med Phys ; 43(6): 3178-3205, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27277063

RESUMO

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used in the evaluation of innovative devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining the equivalence of the innovative treatment modality to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of innovative radiotherapy devices or applications is a critical part in which physicists should be actively involved. The physicist's role, along with physician colleagues, in this process is highlighted for innovative brachytherapy devices and applications and includes evaluation of (1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, (2) risks and benefits from a regulatory and safety perspective, and (3) resource assessment and preparedness. Further, it is suggested that any developed calibration methods be traceable to a primary standards dosimetry laboratory (PSDL) such as the National Institute of Standards and Technology in the U.S. or to other PSDLs located elsewhere such as in Europe. Clinical users should follow standards as approved by their country's regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the Accredited Dosimetry Calibration Laboratories in the U.S. is encouraged before a source is introduced into widespread routine clinical use. The American Association of Physicists in Medicine and the Groupe Européen de Curiethérapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) have developed guidelines for the safe and consistent application of brachytherapy using innovative devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. Nuclear Regulatory Commission, U.S. Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, U.S. Food and Drug Administration, European Commission for CE Marking (Conformité Européenne), and institutional review boards and radiation safety committees.

19.
Brachytherapy ; 14(6): 840-58, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26319367

RESUMO

PURPOSE: Nonmelanoma skin cancers (NMSCs) are the most common type of human malignancy. Although surgical techniques are the standard treatment, radiation therapy using photons, electrons, and brachytherapy (BT) (radionuclide-based and electronic) has been an important mode of treatment in specific clinical situations. The purpose of this work is to provide a clinical and dosimetric summary of the use of BT for the treatment of NMSC and to describe the different BT approaches used in treating cutaneous malignancies. METHODS AND MATERIALS: A group of experts from the fields of radiation oncology, medical physics, and dermatology, who specialize in managing cutaneous malignancies reviewed the literature and compiled their clinical experience regarding the clinical and dosimetric aspects of skin BT. RESULTS: A dosimetric and clinical review of both high dose rate ((192)Ir) and electronic BT treatment including surface, interstitial, and custom mold applicators is given. Patient evaluation tools such as staging, imaging, and patient selection criteria are discussed. Guidelines for clinical and dosimetric planning, appropriate margin delineation, and applicator selection are suggested. Dose prescription and dose fractionation schedules, as well as prescription depth are discussed. Commissioning and quality assurance requirements are also outlined. CONCLUSIONS: Given the limited published data for skin BT, this article is a summary of the limited literature and best practices currently in use for the treatment of NMSC.


Assuntos
Braquiterapia/métodos , Carcinoma Basocelular/radioterapia , Carcinoma de Células Escamosas/radioterapia , Neoplasias Cutâneas/radioterapia , Sociedades Médicas , Braquiterapia/instrumentação , Carcinoma Basocelular/patologia , Carcinoma de Células Escamosas/patologia , Fracionamento da Dose de Radiação , Humanos , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Garantia da Qualidade dos Cuidados de Saúde , Neoplasias Cutâneas/patologia , Estados Unidos
20.
J Contemp Brachytherapy ; 7(2): 189-95, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26034501

RESUMO

A new electronic brachytherapy unit from Elekta, called Esteya(®), has recently been introduced to the market. As a part of the standards in radiation oncology, an acceptance testing and commissioning must be performed prior to treatment of the first patient. In addition, a quality assurance program should be implemented. A complete commissioning and periodic testing of the Esteya(®) device using the American Association of Physicists in Medicine (AAPM), Groupe Européen de Curiethérapie and the European Society for Radiotherapy & Oncology (GEC-ESTRO) guidelines for linacs and brachytherapy units as well as our personal experience is described in this paper. In addition to the methodology, recommendations on equipment required for each test are provided, taking into consideration their availability and traceability of the detectors. Finally, tolerance levels for all the tests are provided, and a specific frequency for each test is suggested.

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