CT number calibration audit in photon radiation therapy.

BACKGROUND: Inadequate computed tomography (CT) number calibration curves affect dose calculation accuracy. Although CT number calibration curves registered in treatment planning systems (TPSs) should be consistent with human tissues, it is unclear whether adequate CT number calibration is performed because CT number calibration curves have not been assessed for various types of CT number calibration phantoms and TPSs. PURPOSE: The purpose of this study was to investigate CT number calibration curves for mass density (ρ) and relative electron density (ρe ). METHODS: A CT number calibration audit phantom was sent to 24 Japanese photon therapy institutes from the evaluating institute and scanned using their individual clinical CT scan protocols. The CT images of the audit phantom and institute-specific CT number calibration curves were submitted to the evaluating institute for analyzing the calibration curves registered in the TPSs at the participating institutes. The institute-specific CT number calibration curves were created using commercial phantom (Gammex, Gammex Inc., Middleton, WI, USA) or CIRS phantom (Computerized Imaging Reference Systems, Inc., Norfolk, VA, USA)). At the evaluating institute, theoretical CT number calibration curves were created using a stoichiometric CT number calibration method based on the CT image, and the institute-specific CT number calibration curves were compared with the theoretical calibration curve. Differences in ρ and ρe over the multiple points on the curve (Δρm and Δρe,m , respectively) were calculated for each CT number, categorized for each phantom vendor and TPS, and evaluated for three tissue types: lung, soft tissues, and bones. In particular, the CT-ρ calibration curves for Tomotherapy TPSs (ACCURAY, Sunnyvale, CA, USA) were categorized separately from the Gammex CT-ρ calibration curves because the available tissue-equivalent materials (TEMs) were limited by the manufacturer recommendations. In addition, the differences in ρ and ρe for the specific TEMs (ΔρTEM and Δρe,TEM , respectively) were calculated by subtracting the ρ or ρe of the TEMs from the theoretical CT-ρ or CT-ρe calibration curve. RESULTS: The mean ± standard deviation (SD) of Δρm and Δρe,m for the Gammex phantom were -1.1 ± 1.2 g/cm3 and -0.2 ± 1.1, -0.3 ± 0.9 g/cm3 and 0.8 ± 1.3, and -0.9 ± 1.3 g/cm3 and 1.0 ± 1.5 for lung, soft tissues, and bones, respectively. The mean ± SD of Δρm and Δρe,m for the CIRS phantom were 0.3 ± 0.8 g/cm3 and 0.9 ± 0.9, 0.6 ± 0.6 g/cm3 and 1.4 ± 0.8, and 0.2 ± 0.5 g/cm3 and 1.6 ± 0.5 for lung, soft tissues, and bones, respectively. The mean ± SD of Δρm for Tomotherapy TPSs was 2.1 ± 1.4 g/cm3 for soft tissues, which is larger than those for other TPSs. The mean ± SD of Δρe,TEM for the Gammex brain phantom (BRN-SR2) was -1.8 ± 0.4, implying that the tissue equivalency of the BRN-SR2 plug was slightly inferior to that of other plugs. CONCLUSIONS: Latent deviations between human tissues and TEMs were found by comparing the CT number calibration curves of the various institutes.

A virtual audit system for intensity-modulated radiation therapy credentialing in Japan Clinical Oncology Group clinical trials: A pilot study.

PURPOSE: The Medical Physics Working Group of the Radiation Therapy Study Group at the Japan Clinical Oncology Group is currently developing a virtual audit system for intensity-modulated radiation therapy dosimetry credentialing. The target dosimeters include films and array detectors, such as ArcCHECK (Sun Nuclear Corporation, Melbourne, Florida, USA) and Delta4 (ScandiDos, Uppsala, Sweden). This pilot study investigated the feasibility of our virtual audit system using previously acquired data. METHODS: We analyzed 46 films (32 and 14 in the axial and coronal planes, respectively) from 29 institutions. Global gamma analysis between measured and planned dose distributions used the following settings: 3%/3 mm criteria (the dose denominator was 2 Gy), 30% threshold dose, no scaling of the datasets, and 90% tolerance level. In addition, 21 datasets from nine institutions were obtained for array evaluation. Five institutions used ArcCHECK, while the others used Delta4. Global gamma analysis was performed with 3%/2 mm criteria (the dose denominator was the maximum calculated dose), 10% threshold dose, and 95% tolerance level. The film calibration and gamma analysis were conducted with in-house software developed using Python (version 3.9.2). RESULTS: The means ± standard deviations of the gamma passing rates were 99.4 ± 1.5% (range, 92.8%-100%) and 99.2 ± 1.0% (range, 97.0%-100%) in the film and array evaluations, respectively. CONCLUSION: This pilot study demonstrated the feasibility of virtual audits. The proposed virtual audit system will contribute to more efficient, cheaper, and more rapid trial credentialing than on-site and postal audits; however, the limitations should be considered when operating our virtual audit system.

Establishing quality indicators to comprehensively assess quality assurance and patient safety in radiotherapy and their relationship with an institution's background.

BACKGROUND AND PURPOSE: Quality indicators (QIs) for radiotherapy have been proposed by several groups, but no study has been conducted to correlate the implementation of indicators specific to patient safety over the course of the clinical process with an institution's background. An initial large-scale survey was conducted to understand the implementation status of QIs established for quality assurance and patient safety in radiotherapy and the relationship between implementation status and an institutions' background. MATERIALS AND METHOD: Overall, 68 QIs that were established by this research team after a pilot survey were used to assess structures and processes for quality assurance and patient safety. Data on the implementation of QIs and the institutions' backgrounds were obtained from designated cancer care hospitals in Japan. RESULTS: Overall, 284 institutions (72 %) responded and had a median QI achievement rate of 60.8 %. QIs with low implementation rates, such as the implementation of an error reporting system and establishment of a quality assurance department, were identified. The QI achievement rate and scale of the institution were positively correlated, and the achievement rate of all QIs was significantly higher (p < 0.001) in institutions capable of advanced treatments, such as intensity-modulated radiotherapy, and those with a quality assurance department. CONCLUSION: A large-scale survey on QIs revealed their implementation and relationship with a facility's background. QIs that require improvement were identified, and that these QIs might be effective in providing advanced medical care to many patients.

Organs-at-risk dose constraints in head and neck intensity-modulated radiation therapy using a dataset from a multi-institutional clinical trial (JCOG1015A1).

BACKGROUND: JCOG1015A1 is an ancillary research study to determine the organ-specific dose constraints in head and neck carcinoma treated with intensity-modulated radiation therapy (IMRT) using data from JCOG1015. METHODS: Individual patient data and dose-volume histograms of organs at risk (OAR) were collected from 74 patients with nasopharyngeal carcinoma treated with IMRT who enrolled in JCOG1015. The incidence of late toxicities was evaluated using the cumulative incidence method or prevalence proportion. ROC analysis was used to estimate the optimal DVH cut-off value that predicted toxicities. RESULTS: The 5-year cumulative incidences of Grade (G) 1 myelitis, ≥ G1 central nervous system (CNS) necrosis, G2 optic nerve disorder, ≥ G2 dysphagia, ≥ G2 laryngeal edema, ≥ G2 hearing impaired, ≥ G2 middle ear inflammation, and ≥ G1 hypothyroidism were 10%, 5%, 2%, 11%, 5%, 26%, 34%, and 34%, respectively. Significant associations between DVH parameters and incidences of toxicities were observed in the brainstem for myelitis (D1cc ≥ 55.8 Gy), in the brain for CNS necrosis (D1cc ≥ 72.1 Gy), in the eyeball for optic nerve disorder (Dmax ≥ 36.6 Gy), and in the ipsilateral inner ear for hearing impaired (Dmean ≥ 44 Gy). The optic nerve, pharyngeal constrictor muscle (PCM), and thyroid showed tendencies between DVH parameters and toxicity incidence. The prevalence proportion of G2 xerostomia at 2 years was 17 versus 6% (contralateral parotid gland Dmean ≥ 25.8 Gy vs less). CONCLUSIONS: The dose constraint criteria were appropriate for most OAR in this study, although more strict dose constraints might be necessary for the inner ear, PCM, and brainstem.

[Introduction of Quality Indicators into Radiotherapy Departments in Japan].

This study investigates the quality indicators (QIs) of medical care that are expected to be introduced to radiotherapy departments in Japan and evaluates whether the QIs reflect the characteristics of the treatment facilities. For this purpose, a questionnaire survey was administered to radiotherapy treatment facilities in Japan. A consensus of early QI candidates was obtained from the panel members. The characteristics identified in the candidate QIs were subdivided into 140 items covering 27 domains of medical-care contents in radiotherapy departments. These 140 items were compiled into a questionnaire, which was administered to 15 treatment facilities in Japan. The primary results indicated that 36 items in five domains are useful QI contents. The secondary findings indicated that the provision of advanced radiotherapy to several patients, the waiting time, and the radiotherapy initiated depend on the manpower of the departmental staff.

An overview of the medical-physics-related verification system for radiotherapy multicenter clinical trials by the Medical Physics Working Group in the Japan Clinical Oncology Group-Radiation Therapy Study Group.

The Japan Clinical Oncology Group-Radiation Therapy Study Group (JCOG-RTSG) has initiated several multicenter clinical trials for high-precision radiotherapy, which are presently ongoing. When conducting multi-center clinical trials, a large difference in physical quantities, such as the absolute doses to the target and the organ at risk, as well as the irradiation localization accuracy, affects the treatment outcome. Therefore, the differences in the various physical quantities used in different institutions must be within an acceptable range for conducting multicenter clinical trials, and this must be verified with medical physics consideration. In 2011, Japan's first Medical Physics Working Group (MPWG) in the JCOG-RTSG was established to perform this medical-physics-related verification for multicenter clinical trials. We have developed an auditing method to verify the accuracy of the absolute dose and the irradiation localization. Subsequently, we credentialed the participating institutions in the JCOG multicenter clinical trials that were using stereotactic body radiotherapy (SBRT) for lungs, intensity-modulated radiotherapy (IMRT) and volumetric-modulated arc therapy (VMAT) for several disease sites, and proton beam therapy (PT) for the liver. From the verification results, accuracies of the absolute dose and the irradiation localization among the participating institutions of the multicenter clinical trial were assured, and the JCOG clinical trials could be initiated.

[Summary of the Report of Task Group 100 of the AAPM: Application of Risk Analysis Methods to Radiation Therapy Quality Management].

In 2016, the American Association of Physicists in Medicine (AAPM) has published a report of task group (TG) 100 with a completely new concept, entitled "application of risk analysis methods to radiation therapy quality management." TG-100 proposed implementation of risk analysis in radiotherapy to prevent harmful radiotherapy accidents. In addition, it enables us to conduct efficient and effective quality management in not only advanced radiotherapy such as intensity-modulated radiotherapy and image-guided radiotherapy but also new technology in radiotherapy. It should be noted that treatment process in modern radiotherapy is absolutely more complex and it needs skillful staff and adequate resources. TG-100 methodology could identify weakness in radiotherapy procedure through assessment of failure modes that could occur in overall treatment processes. All staff in radiotherapy have to explore quality management in radiotherapy safety.

A phase II study of adaptive two-step intensity-modulated radiation therapy (IMRT) with chemotherapy for loco-regionally advanced nasopharyngeal cancer (JCOG1015).

BACKGROUND: A phase II study of adaptive two-step intensity-modulated radiotherapy (IMRT) with chemotherapy for nasopharyngeal cancer (NPC) (JCOG1015) was conducted to evaluate the efficacy and safety. METHODS: Patients aged 20-75 years with stages II-IVB NPC were enrolled. As adaptive two-step IMRT, computed tomography planning was performed twice before IMRT for the initial plan of 46 Gy/23 fractions and during treatment for the boost plan of 24 Gy/12 fractions with a total dose of 70 Gy. Chemotherapy (cisplatin 80 mg/m2/3-weeks × 3 courses) was administered concurrently with IMRT, followed by adjuvant chemotherapy (cisplatin at 70 mg/m2 with 5-FU 700 at mg/m2 for 5 days/4 weeks × 3 courses). RESULTS: Between 2011 and 2014, 75 patients were enrolled from 12 institutions. The 3-year overall survival (OS) for the 75 patients was 88%, and the upper and lower limits of the 95% CI of 78%-94% were higher than the expected 3-year OS of 75% for the target population adjusted by the actual proportion of stage II:III:IV = 21%:44%:35%. The 3-year progression-free survival (PFS) and loco-regional PFS were 71% [59-80%] and 77% [66-85%], respectively. Although no grade 4-5 late toxicities were observed, 15 patients (20%) developed grade 3 late toxicities. Grade 2 xerostomia was noted in 26%, 12%, and 9% at 1, 2, and 3 years after starting IMRT, respectively. CONCLUSIONS: Adaptive two-step IMRT for NPC demonstrated an excellent 3-year OS with acceptable toxicities. This method may be one treatment option for locally advanced NPC.

An end-to-end postal audit test to examine the coincidence between the imaging isocenter and treatment beam isocenter of the IGRT linac system for Japan Clinical Oncology Group (JCOG) clinical trials.

PURPOSE: The aim of this study was to develop an end-to-end postal audit test to examine the coincidence between the imaging isocenter and treatment beam isocenter of the image guided radiotherapy (IGRT) linac system for Japan Clinical Oncology Group (JCOG) trials, as a part of IGRT credentialing of institutions participating in JCOG trials. METHODS: We developed an end-to-end postal audit test to verify radiation positional errors associated with IGRT techniques. This test is intended for simulating a clinical IGRT flow and uses a static cubic phantom measuring 15 × 15 × 15 cm3 and weighing approximately 3.4 kg. The phantom has four gold fiducial markers and a spherical dummy target for setup, with known shift values from the phantom center. Two pairs of Gafchromic RTQA2 films were inserted 5 mm from the phantom's anterior-posterior and right-left surfaces. Radiation positional errors at the isocenter were determined by analyzing the center of the radiation field on the films and the known shift values of the dummy target. The test was performed on 47 IGRT devices at 35 institutions. RESULTS: Radiation positional errors were within acceptance levels (1 mm/1°) for 42 IGRT devices (89.4%) in the first check. Median time to complete IGRT credentialing was 11.5 days. This audit method was applicable for any radiotherapy machine with an IGRT device. CONCLUSIONS: A postal audit test to verify radiation positional errors for JCOG trials was successfully developed. In the postal audit, all but one institution passed this credentialing item within two trials.

Establishment of postal audit system in intensity-modulated radiotherapy by radiophotoluminescent glass dosimeters and a radiochromic film.

We developed an efficient postal audit system to independently assess the delivered dose using radiophotoluminescent glass dosimeters (RPLDs) and the positional differences of fields using EBT3 film at the axial plane for intensity-modulated radiotherapy (IMRT). The audit phantom had a C-shaped target structure as a planning target volume (PTV) with four measurement points for the RPLDs and a cylindrical structure as the organ at risk (OAR) for one measurement point. The phantoms were sent to 24 institutions. Point dose measurements with a 0.6 cm3 PTW farmer chamber were also performed to justify glass dosimetry in IMRT. The measured dose with the RPLDs was compared to the calculated dose in the institution's treatment planning system (TPS). The mean ±â€¯1.96σ of the ratio of the measured dose with the RPLDs to the farmer chamber was 0.997 ±â€¯0.024 with no significant difference (p = .175). The investigations demonstrated that glass dosimetry was reliable with a high measurement accuracy comparable to the chamber. The mean ±â€¯1.96σ for the dose differences with a reference of the TPS dose for the PTV and the OAR was 0.1 ±â€¯2.5% and -2.1 ±â€¯17.8%, respectively. The mean ±â€¯1.96σ for the right-left and the anterior-posterior direction was -0.9 ±â€¯2.8 and 0.5 ±â€¯1.4 mm, respectively. This study is the first report to justify glass dosimetry for implementation in IMRT audit in Japan. We demonstrate that our postal audit system has high accuracy with a high-level criterion of 3%/3 mm.

Independent assessment of source position for gynecological applicator in high-dose-rate brachytherapy.

PURPOSE: The aim of this study is to describe a phantom designed for independent examination of a source position in brachytherapy that is suitable for inclusion in an external auditing program. MATERIAL AND METHODS: We developed a phantom that has a special design and a simple mechanism, capable of firmly fixing a radiochromic film and tandem-ovoid applicators to assess discrepancies in source positions between the measurements and treatment planning system (TPS). Three tests were conducted: 1) reproducibility of the source positions (n = 5); 2) source movements inside the applicator tube; 3) changing source position by changing curvature of the transfer tubes. In addition, as a trial study, the phantom was mailed to 12 institutions, and 23 trial data sets were examined. The source displacement ΔX and ΔY (reference = TPS) were expressed according to the coordinates, in which the positive direction on the X-axis corresponds to the external side of the applicator perpendicular to source transfer direction Y-axis. RESULTS: Test 1: The 1σ fell within 1 mm irrespective of the dwell positions. Test 2: ΔX were greater around the tip of the applicator owing to the source cable. Test 3: All of the source position changes fell within 1 mm. For postal audit, the mean and 1.96σ in ΔX were 0.8 and 0.8 mm, respectively. Almost all data were located within a positive region along the X-axis due to the source cable. The mean and 1.96σ in ΔY were 0.3 and 1.6 mm, respectively. The variance in ΔY was greater than that in ΔX, and large uncertainties exist in the determination of the first dwell position. The 95% confidence limit was 2.1 mm. CONCLUSIONS: In HDR brachytherapy, an effectiveness of independent source position assessment could be demonstrated. The 95% confidence limit was 2.1 mm for a tandem-ovoids applicator.

An on-site audit system for dosimetry credentialing of intensity-modulated radiotherapy in Japanese Clinical Oncology Group (JCOG) clinical trials.

PURPOSE: This study was undertaken to analyze the results of intensity-modulated radiotherapy (IMRT) dosimetry credentialing using a phantom in the Japanese Clinical Oncology Group clinical trials. METHODS: All measurements were performed on-site. The IMRT phantom consisted of a phantom shell and a module. Two types of structures, including a C-shaped planning target volume (PTV) around a column-shaped organ at risk (OAR), were included in the module. Each participating institution was asked to image, plan, and treat the phantom. A prescription dose of 2Gy should cover 95% of the PTV. The plan should limit the maximum doses to the PTV and OAR to less than 110% and 60%, respectively. The pass criteria were ±3% in terms of chamber dosimetry and a difference in profile position ⩽2mm in the high-dose gradient area of film dosimetry. The positional difference was defined as the largest distance between the measured and calculated positions at doses of 60% or 80%. These tolerances were based on the Japanese Society for Radiation Oncology IMRT guidelines. RESULTS: Credentialing was performed on a total of 44 treatment machines in 32 institutions from 2009 to 2015. All differences between measured and planned doses at the measurement points of the PTV were within 3%. The means±standard deviations of the positional differences were 1.0±0.4mm and 0.9±0.3mm without and with the phantom shell, respectively. CONCLUSIONS: The dose differences and positional differences met the desired criteria in all institutions.

[Field Survey Results on Output for X-ray Therapeutic Accelerators in Radiotherapy Institutions of Saitama and Tochigi Prefectures.].

Field survey on output for X-ray therapeutic accelerators took place three times in Saitama Prefecture. The result of the field survey in 1997 showed the different rate from the designated dose at peak depth of 35 beams in 18 institutions. As different rate within +/-5% stood 91.4% in all beams, so different rate within +/-3% stood 85.7% in the same beams. The average different rate from the designated dose at peak depth was 11.06%. The standard deviation of the same condition was 3.72.The result of the field survey in 2005 showed the different rate from the designated dose at correction depth of 36 beams in 18 institutions. As different rate within +/-5% stood 100% in all beams, so different rate within +/-3% stood 91.6% in the same beams. The average different rate from the designated dose at correction depth was +0.80%. The standard deviation of the same condition was 1.46.We understood that the different rate from the designated dose at radiotherapeutic institutions decreased and even the value of the standard deviation was decreasing, by receiving 3 times of field surveys that was held in Saitama Pref. Also we understood that the beam numbers of different rate within +/-5% and the beam numbers of different rate within +/-3% were going up. We recognized that the good result of accurate dose is obtained more, by doing a continual field survey. The field survey was carried out in 2006 in Tochigi Prefecture and was the insufficient result in 10% of institutions.