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

Clinical Impact of a Volumetric Image Method for Confirming Tumor Coverage With Ablation on Patients With Malignant Liver Lesions (COVER-ALL)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Liver Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Ablation Therapy; Procedure: Image-Guided Therapy

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (standard of care ablation); Patients undergo standard of care ablation.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Ablation Therapy; Undergo standard of care ablation; Other Names: Catheter Ablation; ABLATION; Local Ablation Therapy; Local Ablative Therapy
Experimental: Arm II (standard of care ablation, software-aided imaging); Patients undergo standard of care ablation with software-aided imaging (Morfeus).	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Ablation Therapy; Undergo standard of care ablation; Other Names: Catheter Ablation; ABLATION; Local Ablation Therapy; Local Ablative Therapy; Procedure: Image-Guided Therapy; Undergo software-aided imaging (Morfeus); Other Names: Image Guided Therapy; Imaging Guided Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis	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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tumor progression-free survival (LTPFS)	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.	From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years
Intra-hepatic progression-free survival	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.	From date of ablation to earliest date of progression at the ablated lesion, assessed up to 2 years
Overall survival	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.	From date of ablation to death, assessed up to 2 years
Complication rates	Standard summary statistics will be computed for complication rates and compared between arms.	Up to 2 years
Quality of life	Standard summary statistics will be computed for quality of life and compared between arms.	Up to 2 years
Liver function	Standard summary statistics will be computed for liver function and compared between arms.	Up to 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: BRUNO C ODISIO, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2019-0213 (Other Identifier: M D Anderson Cancer Center); NCI-2019-05762 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No