NCT04083378Active, not recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 5 Sept 2019
- Start date
- 10 Jan 2020
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04083378
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 107
- From 10 Jan 2020 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other loco-regional therapies at the target lesion(s) within 30 days of the ablation procedure.
Other illness
- 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.
- Physical or psychological condition which would impair study participation.
Lab values
- Platelet \< 50,000/mm3.
- INR \> 1.5
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
Other
- Patients with uncorrectable coagulopathy.
- ASA (American Society of Anesthesiologists) score of \> 4.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
Related publications
- Quantifying Functional Liver Volume Loss after CT-guided Percutaneous Thermal Ablation: A COVER-ALL Trial Post Hoc Analysis.Radiol Imaging Cancer · 2026 · PMID 41823606
This page is information, not medical advice. Discuss any trial with your doctor.