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

Abstract

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.

Thermal Ablation of Liver Tumors Guided by Augmented Reality: An Initial Clinical Experience

“…Srl, Milan, Italy) [ 36 ]—which enables the automatic segmentation of the liver and intrahepatic blood vessels, and semi-automatically co-registers the target nodules on pre-ablation CT scans with the volumes of necrosis achieved on post-ablation scans using a non-rigid registration tool—was used in order to assess the precision and completeness of the ablation volume achieved ( Figure 1 J). Using a 3D model, the software verified whether the volume of ablative necrosis included entirely or partially the tumor and a pre-defined ablative margin (5-mm thick, in these cases), as well as quantifying, as a percentage, the amount of tumor and ablative margin (if any) external to the ablation volume, thus allowing us to assess the technical success of the procedure [ 37 , 38 ]. After the ablation, all of the operators were interviewed regarding the need for manual adjustments of the HMDs and the occurrence of eye fatigue, dizziness, or cybersickness.…”

Complications Risk Assessment and Imaging Findings of Thermal Ablation Treatment in Liver Cancers: What the Radiologist Should Expect

“…Complications, identified as any unexpected variation from a procedural course, and adverse events, identified as any actual or potential injury related to the treatment, should be assessed according to the following classification systems: (a) the Common Terminology Criteria for Adverse Events standards, (b) the Clavien–Dindo classification, (c) the Society of Interventional Radiology classification, and (d) the Cardiovascular and Interventional Radiological Society of Europe Quality Assurance Document and Standards for Classification of Complications [ 59 ], and these complications should be characterized according to the gravity and the occurrence time (e.g., during treatment, post-treatment, or late) [ 60 , 61 ].…”

“…With regard to complications of ablation treatment, the radiologist should report the technical success, treatment efficacy, and complications [ 59 ]. The complications should be assessed according to the well-defined classification systems (e.g., (a) the Common Terminology Criteria for Adverse Events standards, (b) the Clavien–Dindo classification, (c) the Society of Interventional Radiology classification, and (d) the Cardiovascular and Interventional Radiological Society of Europe Quality Assurance Document and Standards for Classification of Complications).…”

“…Ablation therapies have created a challenge for radiologists, who need to assess response to assess complications related to treatment [ 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 ].…”

Research Highlight: How to Use Technical and Oncologic Outcomes of Image-Guided Tumor Ablation According to Guidelines by Society of Interventional Oncology and DATECAN?

“…To ensure a standardized interpretation and reporting of results and allow for accurate comparison of image-guided tumor ablation outcomes, the SIO and DATECAN group recently published consensus guidelines [ 1 ]. We want to highlight some key points, to facilitate their use in reporting and reviewing research studies.…”