Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liv… (NCT04083378) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study
United States107 participantsStarted 2020-01-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.