Software-Aided Imaging for Liver Cancer Ablation

Overseen By BRUNO C. ODISIO

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

107 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Ablation Therapy, Image-Guided Therapy, Morfeus for liver cancer?

Research shows that using software to predict and verify ablation zones in liver cancer treatment can lead to high technical success and efficacy, with 94% of liver lesions treated successfully and 87% showing complete ablation at follow-up. This suggests that software-aided imaging can improve the precision and effectiveness of liver cancer ablation. ^{1 2 3 4 5}

Is the software-aided imaging treatment for liver cancer ablation safe?

Research shows that image-guided liver tumor ablation, including cryoablation and radiofrequency ablation, is generally safe, but there can be side effects like non-target thermal injury. Studies have evaluated the safety of these procedures, noting some adverse events, but they are considered efficient and safe for treating liver tumors. ^{6 7 8 9 10}

How is the treatment Ablation Therapy for liver cancer unique compared to other treatments?

Ablation Therapy for liver cancer is unique because it uses advanced imaging techniques, like MRI and electrode displacement elastography, to precisely target and treat tumors without the need for surgery. This approach allows for real-time visualization and planning, improving accuracy and effectiveness, especially in patients where surgery is not an option. ^{1 11 12 13 14}

Research Team

Bruno Odisio, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with up to 3 liver tumors, each 1-3 cm in size, who are planning to undergo thermal ablation. They must be able to cover the tumor as seen on CT or MR imaging and have a good performance status (0-2). Participants need functioning kidneys and visible tumors on contrast-enhanced CT. Pregnant or breastfeeding individuals, those with severe coagulopathy, high anesthesia risk (ASA >4), recent other local treatments, active infections that could affect the study, very low platelets or high INR cannot join.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

My kidneys are functioning well.

Target tumor should be visualized on contrast-enhanced CT

Exclusion Criteria

Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test)

I do not have an active infection that could affect the study's safety or results.

You have a physical or mental condition that would make it difficult for you to take part in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo standard of care ablation, with or without software-aided imaging (Morfeus)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up visits at 1, 3, and 6 months, and then at 1 and 2 years

Treatment Details

Interventions

• Ablation Therapy
• Image-Guided Therapy
• Morfeus

Trial Overview The COVER-ALL Study is testing Morfeus software's effectiveness in confirming complete coverage of liver tumors during ablation therapy. It aims to improve accuracy over standard visual checks of pre-and post-procedure CT scans. Patients will receive image-guided therapy followed by quality-of-life assessments through questionnaires.

Participant Groups

Group I: Arm II (standard of care ablation, software-aided imaging) Experimental Treatment 4 Interventions

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

Group II: Arm I (standard of care ablation) Active Control 3 Interventions

Patients undergo standard of care ablation.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A study of 24 liver cancer patients showed that performing transarterial embolization followed by radiofrequency ablation in a single session using cone-beam CT and needle navigation software is both safe and effective, with similar complete response rates to traditional methods.

The single-session approach reduced the number of imaging scans needed (5.0 vs 8.5) and, despite longer procedure times, did not significantly increase radiation exposure, indicating a more efficient treatment option for larger tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Combined Transarterial Embolization and Percutaneous Radiofrequency Ablation for Liver Tumors Using Cone-Beam CT and Needle Navigation Software in a Single Session. Yamada, R., Bassaco, B., Dufour, L., et al.[2019]

In a study of 143 patients undergoing liver tumor cryoablation, factors such as larger tumor size (≥4 cm), low pre-procedural platelet count (<100,000/μL), and prior local radiation therapy were identified as independent risk factors for reduced overall survival.

Interestingly, the occurrence of grade 3 or higher adverse events during the cryoablation procedure did not correlate with decreased survival, suggesting that the procedure itself may be safe in terms of long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periprocedural factors associated with overall patient survival following percutaneous image-guided liver tumor cryoablation. Daye, D., Hu, EY., Glazer, DI., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A deformable model for tracking tumors across consecutive imaging studies. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual Treatment Zone From Cone Beam CT Commonly Alters Treatment Plan and Identifies Tumor at Risk for Under-Treatment in US or US Fusion-Guided Microwave Ablation of Liver Tumors. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Assessing ablation margins of FDG-avid liver tumors during PET/CT-guided thermal ablation procedures: a retrospective study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Imaging to optimize liver tumor ablation. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

State of the art in computer-assisted planning, intervention, and assessment of liver-tumor ablation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Combined Transarterial Embolization and Percutaneous Radiofrequency Ablation for Liver Tumors Using Cone-Beam CT and Needle Navigation Software in a Single Session. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Periprocedural factors associated with overall patient survival following percutaneous image-guided liver tumor cryoablation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of percutaneous, image-guided biopsy of hepatocellular carcinoma with and without concurrent ablation. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Hepato-pericardial fistula following radiofrequency ablation (RFA) for liver metastasis: a case report and review of the literature. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Image-Guided Cryoablation of Hepatic Tumors: Single-Center Experience With Intermediate to Long-Term Outcomes. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Preoperative surgery planning for percutaneous hepatic microwave ablation. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Automatic model-based evaluation of magnetic resonance-guided radio frequency ablation lesions with histological correlation. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Intraoperative magnetic resonance imaging ablation of hepatic tumors. [2007]

14. England pubmed.ncbi.nlm.nih.gov

Physiological Motion Reduction Using Lagrangian Tracking for Electrode Displacement Elastography. [2021]