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

Running, not enrolling · Phase 2

Conditions studied: Malignant Liver Neoplasm

In brief

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.

Key facts

Study ID

NCT04083378

Run by

M.D. Anderson Cancer Center

People needed

107

Starts

2020-01-10

Expected to finish

2026-10-31

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.