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

Phase 3

Active, not recruiting

• Conditions: Malignant Liver Neoplasm
• Interventions: Procedure: Ablation Therapy; Other: Quality-of-Life Assessment; Procedure: Image-Guided Therapy; Other: Questionnaire Administration

• Registration Number: NCT04083378
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-10
• Study Start: 2020-01-10
• Primary Completion: 2023-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 107

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (standard of care ablation)	Quality-of-Life Assessment	Patients undergo standard of care ablation.
Arm I (standard of care ablation)	Ablation Therapy	Patients undergo standard of care ablation.
Arm II (standard of care ablation, software-aided imaging)	Questionnaire Administration	Patients undergo standard of care ablation with software-aided imaging (Morfeus).
Arm I (standard of care ablation)	Questionnaire Administration	Patients undergo standard of care ablation.
Arm II (standard of care ablation, software-aided imaging)	Quality-of-Life Assessment	Patients undergo standard of care ablation with software-aided imaging (Morfeus).
Arm II (standard of care ablation, software-aided imaging)	Ablation Therapy	Patients undergo standard of care ablation with software-aided imaging (Morfeus).
Arm II (standard of care ablation, software-aided imaging)	Image-Guided Therapy	Patients undergo standard of care ablation with software-aided imaging (Morfeus).

Primary Outcome Measures

Name	Time	Method
Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis	Up to 2 years	Will assess whether applying biomechanical models increase the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis. The average minimum ablation margins will be compared between two arms using a 2-sample t-test (or Wilcoxon rank-sum test). The means and corresponding 95% confidence intervals will be reported for both arms of the study.

Secondary Outcome Measures

Name	Time	Method
Complication rates	Up to 2 years	Standard summary statistics will be computed for complication rates and compared between arms.
Liver function	Up to 2 years	Standard summary statistics will be computed for liver function and compared between arms.
Intra-hepatic progression-free survival	From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years	Kaplan-Meier method will be used to estimate intra-hepatic progression-free survival and 95% confidence intervals for the quantiles of the intra-hepatic progression-free survival function based on the method of Brookmeyer and Crowley will be calculated for each arm.
Local tumor progression-free survival (LTPFS)	From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years	Kaplan-Meier method will be used to estimate LTPFS and 95% confidence intervals for the quantiles of the LTPFS function based on the method of Brookmeyer and Crowley will be calculated for each arm.
Quality of life	Up to 2 years	Standard summary statistics will be computed for quality of life and compared between arms.
Overall survival	From date of ablation to death, assessed up to 2 years	Kaplan-Meier method will be used to estimate overall survival and 95% confidence intervals for the quantiles of the overall survival function based on the method of Brookmeyer and Crowley will be calculated for each arm.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States