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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Malignant Liver Neoplasm

Treatments: Procedure: Image-Guided Therapy; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Procedure: Ablation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04083378

2019-0213 (Other Identifier)

NCI-2019-05762 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. 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).
2. Ability to completely cover the target tumor with at least a 5 mm ablation margin.
3. Written informed consent to voluntarily participate in the study and follow-up CT scan schedule
4. Age > 18 years-old
5. Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG])
6. Target tumor should be visualized on contrast-enhanced CT
7. Adequate glomerular filtration rate

Exclusion Criteria

1. 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.
2. Platelet < 50,000/mm3.
3. INR > 1.5
4. Patients with uncorrectable coagulopathy.
5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
6. Physical or psychological condition which would impair study participation.
7. ASA (American Society of Anesthesiologists) score of > 4.
8. Any other loco-regional therapies at the target lesion(s) within 30 days of the ablation procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Arm I (standard of care ablation)

Active Comparator group

Description:

Patients undergo standard of care ablation.

Treatment:

Procedure: Ablation Therapy

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Arm II (standard of care ablation, software-aided imaging)

Experimental group

Description:

Patients undergo standard of care ablation with software-aided imaging (Morfeus).

Treatment:

Procedure: Ablation Therapy

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Procedure: Image-Guided Therapy