Clinical trial NCT04083378: Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study
Official title: Clinical Impact of a Volumetric Image Method for Confirming Tumor Coverage With Ablation on Patients With Malignant Liver Lesions (COVER-ALL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Malignant Liver Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-10
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis
timeFrame: Up to 2 years
Secondary outcomes:
measure: Local tumor progression-free survival (LTPFS)
timeFrame: From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years
measure: Intra-hepatic progression-free survival
timeFrame: From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years
measure: Overall survival
timeFrame: From date of ablation to death, assessed up to 2 years
measure: Complication rates
timeFrame: Up to 2 years
measure: Quality of life
timeFrame: Up to 2 years
measure: Liver function
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: BRUNO C ODISIO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin YM, Paolucci I, Anderson BM, O'Connor CS, Rigaud B, Briones-Dimayuga M, Jones KA, Brock KK, Fellman BM, Odisio BC. Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1860-1867. doi: 10.1007/s00270-022-03255-3. Epub 2022 Sep 4.