NCT04083378 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-03-23

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.

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outcome · POSTED

Cumulative Incidence of 2-year Local Tumor Progression

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outcome · POSTED

Overall Survival

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outcome · POSTED

Intrahepatic Progression-free Survival (for the Randomized Group)

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outcome · POSTED

Extrahepatic Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo standard of care ablation.
intervention Names
Procedure: Ablation Therapy
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
label
Arm I (standard of care ablation)
type
ACTIVE_COMPARATOR
description
Patients undergo standard of care ablation with software-aided imaging (Morfeus).
intervention Names
Procedure: Ablation Therapy
Procedure: Image-Guided Therapy
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
label
Arm II (standard of care ablation, software-aided imaging)
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I (standard of care ablation)
Arm II (standard of care ablation, software-aided imaging)
description
Undergo standard of care ablation
name
Ablation Therapy
other Names
ABLATION
Catheter Ablation
Local Ablation Therapy
Local Ablative Therapy
type
PROCEDURE
arm Group Labels
Arm II (standard of care ablation, software-aided imaging)
description
Undergo software-aided imaging (Morfeus)
name
Image-Guided Therapy
other Names
Image Guided Therapy
Imaging Guided Therapy
type
PROCEDURE
arm Group Labels
Arm I (standard of care ablation)
Arm II (standard of care ablation, software-aided imaging)
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER
arm Group Labels
Arm I (standard of care ablation)
Arm II (standard of care ablation, software-aided imaging)
description
Ancillary studies
name
Questionnaire Administration
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 107
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.
time Frame
Visit 2 (baseline/ablation day)

secondary Outcomes

description
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).
measure
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.
description
The Kaplan-Meier method was used to estimate overall survival
measure
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.
description
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.
measure
Intrahepatic Progression-free Survival (for the Randomized Group)
time Frame
Up to 2 years
description
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.
measure
Extrahepatic Progression-free Survival
time Frame
Up to 2 years

Full study description

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.

Source references

references

citation
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
type
DERIVED
citation
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
type
DERIVED
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.
pmid
36058995
type
DERIVED