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

NCT04083378 | Active Not Recruiting Phase 2 Results DMC

• 2 other identifiers: 2019-0213NCI-2019-05762
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Liver Neoplasm

Outcome Measures

Primary Outcomes (1)

• Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.

  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 Outcomes (4)

• Cumulative Incidence of 2-year Local Tumor Progression

  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

  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)

  Up to 2 years

• Extrahepatic Progression-free Survival

  Up to 2 years

Study Arms (2)

Arm I (standard of care ablation)

ACTIVE COMPARATOR

Patients undergo standard of care ablation.

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

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

EXPERIMENTAL

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

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

Interventions

Ablation Therapy PROCEDURE

Undergo standard of care ablation

Also known as: ABLATION, Catheter Ablation, Local Ablation Therapy, Local Ablative Therapy

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

Image-Guided Therapy PROCEDURE

Undergo software-aided imaging (Morfeus)

Also known as: Image Guided Therapy, Imaging Guided Therapy

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

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

Questionnaire Administration OTHER

Ancillary studies

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Siddiqi NS, Albuquerque J, Paolucci I, Lin YM, O'Connor C, Haddad A, Jones AK, Vauthey JN, Brock KK, Odisio BC. Quantifying Functional Liver Volume Loss after CT-guided Percutaneous Thermal Ablation: A COVER-ALL Trial Post Hoc Analysis. Radiol Imaging Cancer. 2026 Mar;8(2):e250385. doi: 10.1148/rycan.250385.

  PMID: 41823606 DERIVED

• Odisio BC, Albuquerque J, Lin YM, Anderson BM, O'Connor CS, Rigaud B, Briones-Dimayuga M, Jones AK, Fellman BM, Huang SY, Kuban J, Metwalli ZA, Sheth R, Habibollahi P, Patel M, Shah KY, Cox VL, Kang HC, Morris VK, Kopetz S, Javle MM, Kaseb A, Tzeng CW, Cao HT, Newhook T, Chun YS, Vauthey JN, Gupta S, Paolucci I, Brock KK. Software-based versus visual assessment of the minimal ablative margin in patients with liver tumours undergoing percutaneous thermal ablation (COVER-ALL): a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2025 May;10(5):442-451. doi: 10.1016/S2468-1253(25)00024-X. Epub 2025 Mar 13.

  PMID: 40090348 DERIVED

• 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.

  PMID: 36058995 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Catheter Ablation; Radiotherapy, Image-Guided

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Radiotherapy

Results Point of Contact

• Title: Dr. Bruno Odisio
• Organization: The University of Texas MD Anderson Cancer Center

bcodisio@mdanderson.org

(713) 563-1066

Study Officials

• BRUNO C ODISIO

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: January 10, 2020
• Primary Completion: October 31, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 23, 2026
• Results First Posted: November 21, 2025

Record last verified: 2026-03

Locations

US (1)