Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative.

There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes standardized definitions for a broad range of oncologic outcome measures with recommendations on how to uniformly document, analyze, and report outcomes. The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. According to predefined criteria, based on experience with clinical trials, an international panel of 62 experts convened. Recommendations were developed using the validated three-step modified Delphi consensus method. Consensus was reached on when to assess outcomes per patient, per session, or per tumor; on starting and ending time and survival time definitions; and on time-to-event end points. Although no consensus was reached on the preferred classification system to report complications, quality of life, and health economics issues, the panel did agree on using the most recent version of a validated patient-reported outcome questionnaire. This article provides a framework of key opinion leader recommendations with the intent to facilitate a clear interpretation of results and standardize worldwide communication. Widespread adoption will improve reproducibility, allow for accurate comparisons, and avoid misinterpretations in the field of interventional oncology research. Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Liddell in this issue.

Image-guided tumor ablation: standardization of terminology and reporting criteria--a 10-year update.

Image-guided tumor ablation has become a well-established hallmark of local cancer therapy. The breadth of options available in this growing field increases the need for standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison among treatments that use different technologies, such as chemical (eg, ethanol or acetic acid) ablation, thermal therapies (eg, radiofrequency, laser, microwave, focused ultrasound, and cryoablation) and newer ablative modalities such as irreversible electroporation. This updated consensus document provides a framework that will facilitate the clearest communication among investigators regarding ablative technologies. An appropriate vehicle is proposed for reporting the various aspects of image-guided ablation therapy including classification of therapies, procedure terms, descriptors of imaging guidance, and terminology for imaging and pathologic findings. Methods are addressed for standardizing reporting of technique, follow-up, complications, and clinical results. As noted in the original document from 2003, adherence to the recommendations will improve the precision of communications in this field, leading to more accurate comparison of technologies and results, and ultimately to improved patient outcomes. Online supplemental material is available for this article .

Image-guided tumor ablation: standardization of terminology and reporting criteria--a 10-year update.

Image-guided tumor ablation has become a well-established hallmark of local cancer therapy. The breadth of options available in this growing field increases the need for standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison among treatments that use different technologies, such as chemical (eg, ethanol or acetic acid) ablation, thermal therapies (eg, radiofrequency, laser, microwave, focused ultrasound, and cryoablation) and newer ablative modalities such as irreversible electroporation. This updated consensus document provides a framework that will facilitate the clearest communication among investigators regarding ablative technologies. An appropriate vehicle is proposed for reporting the various aspects of image-guided ablation therapy including classification of therapies, procedure terms, descriptors of imaging guidance, and terminology for imaging and pathologic findings. Methods are addressed for standardizing reporting of technique, follow-up, complications, and clinical results. As noted in the original document from 2003, adherence to the recommendations will improve the precision of communications in this field, leading to more accurate comparison of technologies and results, and ultimately to improved patient outcomes.

Image-guided tumor ablation: standardization of terminology and reporting criteria.

The field of interventional oncology with use of image-guided tumor ablation requires standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison between treatments that use different technologies, such as chemical (ethanol or acetic acid) ablation, and thermal therapies, such as radiofrequency (RF), laser, microwave, ultrasound, and cryoablation. This document provides a framework that will hopefully facilitate the clearest communication between investigators and will provide the greatest flexibility in comparison between the many new, exciting, and emerging technologies. An appropriate vehicle for reporting the various aspects of image-guided ablation therapy, including classification of therapies and procedure terms, appropriate descriptors of imaging guidance, and terminology to define imaging and pathologic findings, are outlined. Methods for standardizing the reporting of follow-up findings and complications and other important aspects that require attention when reporting clinical results are addressed. It is the group's intention that adherence to the recommendations will facilitate achievement of the group's main objective: improved precision and communication in this field that lead to more accurate comparison of technologies and results and, ultimately, to improved patient outcomes. The intent of this standardization of terminology is to provide an appropriate vehicle for reporting the various aspects of image-guided ablation therapy.

Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study).

BACKGROUND: Radiofrequency ablation is an accepted treatment for non-surgical patients with liver cancer. The purpose of this study was to identify the feasibility, safety, and effectiveness of percutaneous radiofrequency ablation of malignant lung tumours. METHODS: Between July 1, 2001, and Dec 10, 2005, a series of 106 patients with 183 lung tumours that were 3.5 cm in diameter or smaller (mean 1.7 cm [SD 1.3]) were enrolled in a prospective, intention-to-treat, single-arm, multicentre clinical trial from seven centres in Europe, the USA, and Australia. Proof of malignancy was obtained by biopsy in all patients. Diagnoses included non-small-cell lung cancer (NSCLC) in 33 patients, metastasis from colorectal carcinoma in 53 patients, and metastasis from other primary malignancies in 20 patients. All patients were considered by the treating physician to be unsuitable for surgery and unfit for radiotherapy or chemotherapy. Patients underwent radiofrequency ablation in accordance with standard rules for CT-guided lung biopsy and were then followed for up to 2 years. Primary endpoints were technical success (defined as correct placement of the ablation device into all tumour targets with completion of the planned ablation protocol), safety (including identification of treatment-related complications and changes in pulmonary function), and confirmed complete response of tumours (according to modified Response Evaluation Criteria in Solid Tumors). Secondary endpoints were overall survival, cancer-specific survival, and quality of life. This trial is registered with ClinicalTrials.gov, number NCT00690703. FINDINGS: Correct placement of the ablation device into the target tumour with completion of the planned treatment protocol was feasible in 105 (99%) of 106 patients. The technical failure in one patient was caused by the inability to place the device inside a small tumour. No procedure-related deaths occurred in any of the 137 ablation procedures. Major complications consisted of pneumothorax (n=27) or pleural effusion (n=4), which needed drainage. No significant worsening of pulmonary function was noted. A confirmed complete response of target tumours lasting at least 1 year was shown in 75 (88%) of 85 assessable patients. No differences in response were noted between patients with NSCLC or lung metastases. Overall survival was 70% (95% CI 51-83%) at 1 year and 48% (30-65%) at 2 years in patients with NSCLC, 89% (76-95%) at 1 year and 66% (53-79%) at 2 years in patients with colorectal metastases, and 92% (65-99%) at 1 year and 64% (43-82%) at 2 years in patients with other metastases. Cancer-specific survival was 92% (78-98%) at 1 year and 73% (54-86%) at 2 years in patients with NSCLC, 91% (78-96%) at 1 year and 68% (54-80%) at 2 years in patients with colorectal metastases, and 93% (67-99%) at 1 year and 67% (48-84%) at 2 years in patients with other metastases. Patients with stage I NSCLC (n=13) had a 2-year overall survival of 75% (45-92%) and a 2-year cancer-specific survival of 92% (66-99%). INTERPRETATION: Percutaneous radiofrequency ablation yields high proportions of sustained complete responses in properly selected patients with pulmonary malignancies, and is associated with acceptable morbidity. Randomised controlled trials comparing radiofrequency ablation with standard non-surgical treatment options are warranted.

Five-year survival following radiofrequency ablation of small, solitary, hepatic colorectal metastases.

PURPOSE: Radiofrequency (RF) ablation is an increasingly accepted treatment for nonsurgical candidates with a limited number of colorectal hepatic metastases. RF ablation is most effective in tumors smaller than 4.0 cm. This report describes 5-year survival in patients with single tumors with a maximum diameter of 4 cm. MATERIALS AND METHODS: Forty of 291 patients (14%; 24 men, 16 women; mean age, 67 years; age range, 34-86 y) with no or treated extrahepatic disease were identified who were not candidates for resection and who had a minimum follow-up of 6 months. Sixteen had undergone hepatic resection and two had undergone lung resection and lung ablation. Thirty-two (80%) received chemotherapy. Thirty-five were treated under general anesthesia and five under conscious sedation. Our standard ablation protocol used internally water-cooled electrodes introduced percutaneously with ultrasonography and computed tomography guidance and monitoring. Follow-up data were obtained from primary care physicians or oncologists. RESULTS: Mean tumor diameter was 2.3 cm (range, 0.8-4.0 cm). There were two successfully treated systemic complications: a chest infection and an exacerbation of asthma. There were no local complications. Mean follow-up was 38 months (range, 6-132 months). The median survival duration and 1-, 3-, and 5-year survival rates were 59 months and 97%, 84%, 40%, respectively, after ablation; and 63 months, 100%, 88%, and 54%, respectively, from the diagnosis of liver metastases. History of liver resection did not impact survival. CONCLUSIONS: RF ablation of solitary liver metastases 4 cm or smaller can be performed with minimal morbidity and results in excellent long-term survival, approaching that of surgical resection, even in patients who are not surgical candidates.

Radiofrequency ablation of lung metastases: factors influencing success.

This paper analyses the factors associated with successful radiofrequency ablation (RFA) of lung metastases. The study group comprised 37 patients [19 female, mean age 61 (34-83)] with 72 metastases who had follow-up CT scans available for analysis and for those with no recurrence >6 months follow-up. Internally cooled electrodes were used in 64 and expandable electrodes in 8. The tumour size and location, electrode type, number of ablations, duration of ablation, year of treatment and tumour contact with vessels larger than 3 mm were recorded. The mean tumour diameter was 1.8 cm (0.4-6.6 cm). Mean follow-up in those without recurrence was 13.1 months (6-48). Recurrence was common in larger tumours, occurring in 7/7 (100%) tumours >3.5 cm compared with 18/65 (28%) < or = 3.5 cm (P < 0.01). Recurrence occurred in 14/24 (58%) tumours in direct contact with large vessels compared with 11/48 (23%) of the remainder (P = 0.04). On multivariate analysis, size was the dominant feature (P = 0.013); vessel contact and peripheral location did not reach significance (P = 0.056 and 0.054 respectively). Peripheral tumours less than 3.5 cm with no large vessel contact are the optimal tumours for RFA.

Image-guided tumor ablation: standardization of terminology and reporting criteria.

The field of interventional oncology with use of image-guided tumor ablation requires standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison between treatments that use different technologies, such as chemical (ethanol or acetic acid) ablation, and thermal therapies, such as radiofrequency (RF), laser, microwave, ultrasound, and cryoablation. This document provides a framework that will hopefully facilitate the clearest communication between investigators and will provide the greatest flexibility in comparison between the many new, exciting, and emerging technologies. An appropriate vehicle for reporting the various aspects of image-guided ablation therapy, including classification of therapies and procedure terms, appropriate descriptors of imaging guidance, and terminology to define imaging and pathologic findings, are outlined. Methods for standardizing the reporting of follow-up findings and complications and other important aspects that require attention when reporting clinical results are addressed. It is the group's intention that adherence to the recommendations will facilitate achievement of the group's main objective: improved precision and communication in this field that lead to more accurate comparison of technologies and results and, ultimately, to improved patient outcomes. The intent of this standardization of terminology is to provide an appropriate vehicle for reporting the various aspects of image-guided ablation therapy.

Image-guided tumor ablation: standardization of terminology and reporting criteria.

The field of interventional oncology with use of image-guided tumor ablation requires standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison between treatments that use different technologies, such as chemical (ethanol or acetic acid) ablation, and thermal therapies, such as radiofrequency, laser, microwave, ultrasound, and cryoablation. This document provides a framework that will hopefully facilitate the clearest communication between investigators and will provide the greatest flexibility in comparison between the many new, exciting, and emerging technologies. An appropriate vehicle for reporting the various aspects of image-guided ablation therapy, including classification of therapies and procedure terms, appropriate descriptors of imaging guidance, and terminology to define imaging and pathologic findings, are outlined. Methods for standardizing the reporting of follow-up findings and complications and other important aspects that require attention when reporting clinical results are addressed. It is the group's intention that adherence to the recommendations will facilitate achievement of the group's main objective: improved precision and communication in this field that lead to more accurate comparison of technologies and results and, ultimately, to improved patient outcomes.

Prospective study comparing multislice CT colonography with colonoscopy in the detection of colorectal cancer and polyps.

PURPOSE: Multislice CT colonography is an alternative to colonoscopy. The purpose of this study was to compare multislice CT colonography with colonoscopy in the detection of colorectal polyps and cancers. METHODS: Between June 2000 and December 2001, 45 males and 35 females (median age, 68 (29-83) years) with symptoms of colorectal disease were studied prospectively. All patients underwent multislice CT colonography and colonoscopy, and the findings were compared. RESULTS: Colonoscopy was incomplete in 18 (22 percent) patients because of obstructing lesions or technical difficulty, and multislice CT colonography was unsuccessful in 4 (5 percent) because of fecal residue. Colonoscopy was normal in 26 patients and detected 29 colorectal cancers and 33 polyps in 35 patients, diverticulosis in 16 patients, and colitis in 3 patients. Multislice CT colonography identified 28 of 29 colorectal cancers with one false negative and one false positive (sensitivity, 97 percent; specificity, 98 percent; positive predictive value, 96 percent; negative predictive value, 98 percent). Multislice CT colonography identified all 12 polyps measuring >or=10 mm in diameter (sensitivity, 100 percent), 5 of 6 measuring 6 to 9 mm in diameter (sensitivity, 83 percent), 8 of 15 polyps or=6 mm is similar to colonoscopy. Multislice CT colonography allows clinical staging of colorectal cancers, outlines the whole length of the colon in obstructing carcinoma when colonoscopy fails, and can identify extracolonic causes of abdominal symptoms.

Image-guided tumor ablation: proposal for standardization of terms and reporting criteria.

The field of image-guided tumor ablation requires standardization of terms and reporting criteria to facilitate effective communication of ideas and appropriate comparison between treatments with different technologies, such as chemical ablation (ethanol or acetic acid) and thermal therapies, such as radiofrequency, laser, microwave, ultrasound, and cryoablation. On the basis of this premise, a working committee was established with the goal of producing a proposal on such standardization. The intent of the Working Group is to provide a framework that will facilitate the clearest communication between investigators and will provide the greatest flexibility in comparisons between the many new, exciting, and emerging technologies. The members of the Working Group now propose a vehicle for reporting the various aspects of image-guided ablation therapy, including classifications of therapies and procedures, appropriate descriptors of image guidance, and terms to define imaging and pathologic findings. Methods for standardizing the reporting of follow-up findings and complications and other important aspects that require attention when reporting clinical results are addressed. It is the group's hope and intention that adherence to the recommendations of this proposal will facilitate achievement of the group's main objective: improved precision and communication in this field that lead to more accurate comparison of technologies and results and ultimately to improved patient outcomes.