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

March 9, 2026 updated by: M.D. Anderson Cancer Center

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

Intervention / Treatment

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 (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.
Time Frame: Visit 2 (baseline/ablation day)
For control group, MAM was assessed by rigid co-registration with side-by-side juxtaposition to verify applicator placement and by visual landmark-based CT measurements on CT workstation (Siemens Healthineers; Forchheim, Germany). For experimental group, CT images were processed with a software-based method on a radiation treatment planning system (Raystation, RaySearch Laboratories; Stockholm, Sweden) with biomechanical deformable imaging registration coupled with AI-based autosegmentation. For experimental group, interventional radiologist (IR) was informed of ablation applicator position relative to tumor on non-contrast CT before thermal ablation energy delivery and of MAM results (including spatial location of suboptimal margins) generated by software-based assessment, with this information not disclosed to IR in control group. Software-based assessment was used to compare MAMs results between both study groups with a two-sample t-test.
Visit 2 (baseline/ablation day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of 2-year Local Tumor Progression
Time Frame: Time to local tumor progression (LTP) was measured from ablation to earliest LTP or death (competing event). Follow-up imaging continued up to 24 months.
A competing risk analysis was conducted to estimate the 2-year cumulative incidence of local tumor progression. Progression followed ablation reporting standards and RECIST v1.1 (mRECIST for HCC).
Time to local tumor progression (LTP) was measured from ablation to earliest LTP or death (competing event). Follow-up imaging continued up to 24 months.
Overall Survival
Time Frame: Overall survival was measured from the date of ablation to the date of death from any cause. Patients still alive were censored at the date of last clinic visit, with follow-up up to 24 months after ablation.
The Kaplan-Meier method was used to estimate overall survival
Overall survival was measured from the date of ablation to the date of death from any cause. Patients still alive were censored at the date of last clinic visit, with follow-up up to 24 months after ablation.
Intrahepatic Progression-free Survival (for the Randomized Group)
Time Frame: Up to 2 years
Competing risk analysis was conducted to estimate the 2-year intrahepatic (progression outside of ablation zone), considering the progression of the ablated tumor and treating death as a competing event.
Up to 2 years
Extrahepatic Progression-free Survival
Time Frame: Up to 2 years
Competing risk analysis was conducted to estimate the 2-year extrahepatic cumulative incidence of progression, considering the progression of the ablated tumor and treating death as a competing event.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

October 31, 2024

Study Completion (Estimated)

October 31, 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)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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