A Phase 2 interventional study of Ablation Therapy and Image-Guided Therapy in Malignant Liver Neoplasm, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Patients undergo standard of care ablation.
Procedure: Ablation Therapy · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
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
Undergo standard of care ablation
Also known as: ABLATION, Catheter Ablation, Local Ablation Therapy, Local Ablative Therapy
Undergo software-aided imaging (Morfeus)
Also known as: Image Guided Therapy, Imaging Guided Therapy
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
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.
Time frame: Visit 2 (baseline/ablation day)
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 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.
Overall Survival
The Kaplan-Meier method was used to estimate 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.
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.
Time frame: 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.
Time frame: Up to 2 years
MD Anderson Cancer Center
| Milestone | Experimental | Control |
|---|---|---|
| Started | 74 | 26 |
| Completed | 52 | 22 |
| Not completed | 22 | 4 |
| Withdrew: Death | 18 | 4 |
| Withdrew: Lost to follow-up | 4 | 0 |
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.
| mm | Experimental | Control |
|---|---|---|
| Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT. | 6.8 ± 2.9 | 2.2 ± 2.8 |
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).
| percentage of participants | Experimental | Control |
|---|---|---|
| Cumulative Incidence of 2-year Local Tumor Progression | 6 | 17.9 |
The Kaplan-Meier method was used to estimate overall survival
| percentage of participants | Experimental | Control |
|---|---|---|
| Overall Survival | 73.9 (64.2 to 85.0) | 83.6 (70.1 to 99.7) |
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.
| percentage of participants | Experimental | Control |
|---|---|---|
| Intrahepatic Progression-free Survival (for the Randomized Group) | 34.5 (24.8 to 47.8) | 41.4 (25.4 to 67.3) |
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.
| percentage of participants | Experimental | Control |
|---|---|---|
| Extrahepatic Progression-free Survival | 34.5 (24.8 to 47.8) | 41.4 (25.4 to 67.3) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 26/74 (35.1%) | 39/74 (52.7%) | 18/74 (24.3%) |
| Control | 6/26 (23.1%) | 12/26 (46.2%) | 3/26 (11.5%) |
| Event | Experimental | Control |
|---|---|---|
| DeathGeneral disorders | 26/74 | 6/26 |
| Abdominal painGastrointestinal disorders | 8/74 | 3/26 |
| VomitingGastrointestinal disorders | 4/74 | 1/26 |
| NauseaGastrointestinal disorders | 3/74 | 1/26 |
| DiarrheaGastrointestinal disorders | 3/74 | 0/26 |
| DehydrationGeneral disorders | 3/74 | 0/26 |
| Acute kidney injuryRenal and urinary disorders | 1/74 | 1/26 |
| Colonic obstructionGastrointestinal disorders | 2/74 | 1/26 |
| ColitisGastrointestinal disorders | 0/74 | 1/26 |
| FeverGeneral disorders | 0/74 | 1/26 |
| Event | Experimental | Control |
|---|---|---|
| Abdominal painGastrointestinal disorders | 5/74 | 2/26 |
| VomitingGastrointestinal disorders | 4/74 | 0/26 |
| NauseaGeneral disorders | 3/74 | 0/26 |
| FatigueGeneral disorders | 1/74 | 1/26 |
| HematomaVascular disorders | 1/74 | 1/26 |
| Back painMusculoskeletal and connective tissue disorders | 1/74 | 0/26 |
| Chest painCardiac disorders | 1/74 | 0/26 |
| ConstipationGastrointestinal disorders | 1/74 | 0/26 |
| Infection (COVID-19)Infections and infestations | 1/74 | 0/26 |
| FeverGeneral disorders | 1/74 | 0/26 |
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.
| Age, Categorical(Participants) | Experimental | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 52 | 18 | 70 |
| >=65 years | 22 | 8 | 30 |
| Sex: Female, Male(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Female | 31 | 8 | 39 |
| Male | 43 | 18 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 10 |
| Not Hispanic or Latino | 69 | 20 | 89 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Experimental | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 8 | 3 | 11 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 4 | 1 | 5 |
| White | 57 | 18 | 75 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Region of Enrollment(participants) | Experimental | Control | Total |
|---|---|---|---|
| United States | 74 | 26 | 100 |
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M.D. Anderson Cancer Center