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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2026
  • participants needed
    100
  • sponsor
    M.D. Anderson Cancer Center
Updated on 2 September 2021

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.

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 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.

Details
Condition Malignant Liver Neoplasm
Treatment questionnaire administration, quality-of-life assessment, Ablation Therapy, Image-Guided Therapy
Clinical Study IdentifierNCT04083378
SponsorM.D. Anderson Cancer Center
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with =< 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 3 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation
Ability to completely cover the target lesion as determined by routine pre-procedure imaging (CT or magnetic resonance [MR])
Written informed consent to voluntarily participate in the study and follow-up CT scan schedule
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
Patients with implantable pacemakers or other electronic implants
Platelet < 50,000/mm^3
International normalized ratio (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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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