Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study

Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study

Clinical Impact of a Volumetric Image Method for Confirming Tumor Coverage With Ablation on Patients With Malignant Liver Lesions (COVER-ALL)

This phase II trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. The current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (CT) scans. Software-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation.

PRIMARY OBJECTIVE: I. To evaluate if the intra-procedure feedback of a biomechanical deformable registration volumetric image method during percutaneous ablation will increase the minimal ablation margins on a three-dimensional computed tomography-generated analysis. SECONDARY OBJECTIVES: I. To assess whether applying the proposed method during percutaneous ablation improves local tumor progression-free survival (LTPFS) rates. II. Evaluate impact of software use on procedure workflow. III. Impact of software use on complication rates, quality of life, liver function. IV. Evaluate oncological outcomes (intra-hepatic and overall progression-free survivals, and overall survival). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard of care ablation. ARM II: Patients undergo standard of care ablation with software-aided imaging (Morfeus). After completion of study, patients are followed up at 1, 3, and 6 months, and then at 1 and 2 years.

Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis

Will assess whether applying biomechanical models increase the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis. The average minimum ablation margins will be compared between two arms using a 2-sample t-test (or Wilcoxon rank-sum test). The means and corresponding 95% confidence intervals will be reported for both arms of the study.

Kaplan-Meier method will be used to estimate LTPFS and 95% confidence intervals for the quantiles of the LTPFS function based on the method of Brookmeyer and Crowley will be calculated for each arm.

Kaplan-Meier method will be used to estimate intra-hepatic progression-free survival and 95% confidence intervals for the quantiles of the intra-hepatic progression-free survival function based on the method of Brookmeyer and Crowley will be calculated for each arm.

Kaplan-Meier method will be used to estimate overall survival and 95% confidence intervals for the quantiles of the overall survival function based on the method of Brookmeyer and Crowley will be calculated for each arm.

Inclusion Criteria: Patients presenting with ≤ 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 5 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation. Patients with more than 3 tumors might also be eligible in case other tumors can be treated with another curative-intended loco-regional therapy (i.e. surgical resection, radiation therapy). Ability to completely cover the target tumor with at least a 5 mm ablation margin. Written informed consent to voluntarily participate in the study and follow-up CT scan schedule Age > 18 years-old Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG]) Target tumor should be visualized on contrast-enhanced CT Adequate glomerular filtration rate Exclusion Criteria Active bacterial infection or fungal infection on the day of the ablation that, in the opinion of the investigator, would interfere with safe delivery of the study procedure or with the interpretation of study results. Platelet < 50,000/mm3. INR > 1.5 Patients with uncorrectable coagulopathy. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test). Physical or psychological condition which would impair study participation. ASA (American Society of Anesthesiologists) score of > 4. Any other loco-regional therapies at the target lesion(s) within 30 days of the ablation procedure.

Lin YM, Paolucci I, Anderson BM, O'Connor CS, Rigaud B, Briones-Dimayuga M, Jones KA, Brock KK, Fellman BM, Odisio BC. Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1860-1867. doi: 10.1007/s00270-022-03255-3. Epub 2022 Sep 4.