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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05762 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0213 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard of care ablation) | Active Comparator | Patients undergo standard of care ablation. |
|
| Arm II (standard of care ablation, software-aided imaging) | Experimental | Patients undergo standard of care ablation with software-aided imaging (Morfeus). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation Therapy | Procedure | Undergo standard of care ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of 2-year Local Tumor Progression | 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| BRUNO C ODISIO | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41823606 | Derived | 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. | |
| 40090348 | Derived |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
Not provided
Randomized and non-randomized experimental groups were combined as both received the same ablation confirmation (AC) software. Per DSMB recommendation, an interim stopping rule for control enrollment, which was triggered, halting further accrual. Thus, analyses comparing experimental versus control are presented in this simplified structure to ensure consistency in evaluating the novel AC software for liver tumor ablation.
MD Anderson Cancer Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of hepatic mets |
| FG001 | Control | Morfeus software was not used during percutaneous ablation of hepatic mets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2023 |
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|
| Image-Guided Therapy | Procedure | Undergo software-aided imaging (Morfeus) |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
| Overall Survival | 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) | 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 | 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 |
| 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. |
| 36058995 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Randomized and non-randomized experimental groups were combined as both received the same ablation confirmation (AC) software. Per DSMB recommendation, an interim stopping rule for control enrollment, which was triggered, halting further accrual. Thus, analyses comparing experimental versus control are presented in this simplified structure to ensure consistency in evaluating the novel AC software for liver tumor ablation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of hepatic mets |
| BG001 | Control | Morfeus software was not used during percutaneous ablation of hepatic mets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary endpoint included all enrolled patients | Posted | Mean | Standard Deviation | mm | Visit 2 (baseline/ablation day) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of 2-year Local Tumor Progression | 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). | The 2-year secondary endpoints were evaluated for the randomized group | Posted | Number | percentage of participants | 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. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The Kaplan-Meier method was used to estimate overall survival | The 2-year secondary endpoints were evaluated for the randomized group | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
|
| |||||||||||||||||||||||||||||
| Secondary | Intrahepatic Progression-free Survival (for the Randomized Group) | 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. | The 2-year secondary endpoints are provided in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Extrahepatic Progression-free Survival | 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. | The 2-year secondary endpoints are provided in this analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
|
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Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure.
Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors | 26 | 74 | 39 | 74 | 18 | 74 |
| EG001 | Control | Morfeus software was not used during the percutaneous ablation of liver tumors | 6 | 26 | 12 | 26 | 3 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Allergic reaction | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Breast infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Bleeding | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Death | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Encephalopathy (liver) | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hepatic failure | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain (hip) | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infection (suspected cholangitis) | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Ischemia (vascular disorder) | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Portal vein thrombosis | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Bleeding (vaginal) | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Infection (Urinary Tract) | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infection (COVID-19) | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Nausea | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rectal pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruno Odisio | The University of Texas MD Anderson Cancer Center | (713) 563-1066 | bcodisio@mdanderson.org |
| Sep 2, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2022 | Oct 8, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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