Software-Aided Imaging for Liver Cancer Ablation

BC
Overseen ByBRUNO C. ODISIO
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a software-aided imaging system, such as Morfeus, to determine if it can enhance the accuracy of ablation therapy, which uses heat to destroy cancer cells, for liver tumors. The goal is to ensure complete coverage and effective treatment of the tumor during the procedure. Participants will be divided into two groups: one receiving standard ablation care and the other using the software-aided imaging for potentially improved results. Eligible participants may have up to three liver tumors and plan to undergo thermal ablation. Those already dealing with liver tumors and considering ablation might find this trial worth exploring. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 prior data suggests that software-aided imaging is safe for liver cancer ablation?

Research has shown that software-aided imaging systems, such as Morfeus, hold promise for improving liver cancer ablation. Ablation is a treatment that removes or destroys tumors. Studies have demonstrated that these software tools help doctors see and confirm the areas they treat during ablation more clearly.

A review of various studies found that the success rate of using these tools immediately after ablation ranged from 81.3% to 100%. This indicates that, in many cases, the software helped ensure the tumor was fully treated. Importantly, these studies identified that using software to check treatment borders is crucial for reducing risk.

Since this trial is in a later phase, there is already some confidence in the safety of using software-aided imaging with ablation. However, like any treatment, risks can occur. Overall, the data so far indicate that this approach is well-tolerated by patients.12345

Why are researchers excited about this trial?

Researchers are excited about software-aided imaging for liver cancer ablation because it could enhance the precision of standard ablation therapy. Unlike typical treatments that rely solely on the physician's skill and standard imaging, this approach uses advanced software to guide the procedure, potentially increasing accuracy and effectiveness. This innovation could improve outcomes by precisely targeting cancer cells while preserving healthy tissue, offering hope for better patient recovery and survival rates.

What evidence suggests that software-aided imaging is effective for liver cancer ablation?

Research shows that software tools like Morfeus can enhance the accuracy of liver tumor treatments. In this trial, one group of participants will receive standard care ablation, while another group will receive standard care ablation with software-aided imaging using Morfeus. Studies have found that this technology ensures the entire tumor is targeted and treated. Accurate targeting is crucial because it reduces the risk of missing cancer cells during the procedure. Evidence suggests that these tools can lead to better outcomes by ensuring full tumor coverage. Additionally, accurate imaging helps verify the success of the treatment immediately after completion. Overall, these tools could improve liver tumor treatments by ensuring complete tumor treatment.12345

Who Is on the Research Team?

BC

Bruno Odisio, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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
See 3 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (standard of care ablation, software-aided imaging)Experimental Treatment4 Interventions
Group II: Arm I (standard of care ablation)Active Control3 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Study Details | NCT04083378 | Software-Aided Imaging ...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 ...
Software-Aided Imaging (Morfeus) for Confirming Tumor ...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 ...
Clinical Trials DetailSoftware-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation. Resources and Links. Phone Number: 1 ...
Software-based assessment of tumor margins after ...Software-based assessment of ablation margin has an emerging role in thermal ablation of hepatic tumors. •. Ablation margin is the only significant risk factor ...
Efficacy of fusion imaging for immediate post‐ablation ...This study examines the efficacy of image fusion strategies immediately post‐ablation in liver neoplasms to determine therapeutic response.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security