Status:
ACTIVE_NOT_RECRUITING
Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Liver Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 live...
Detailed Description
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 ma...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2026
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04083378
Start Date
January 10 2020
End Date
October 31 2026
Last Update
November 21 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030