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Software-Aided Imaging for Liver Cancer Ablation

Phase 3

Waitlist Available

Led By BRUNO C ODISIO

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG])

Adequate glomerular filtration rate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing whether software-aided imaging can improve accuracy and effectiveness of liver ablation, compared to the current standard of visual inspection of CT scans.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed here, side effects may include typical risks associated with ablation procedures such as pain at the treatment site, bleeding due to needle insertion, infection risk from invasive procedure and potential damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidneys are functioning well.

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I have up to 3 liver tumors, each 1-3 cm, planned for a specific heat treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis

Secondary outcome measures

Complication rates

Intra-hepatic progression-free survival

Liver function

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (standard of care ablation, software-aided imaging)Experimental Treatment4 Interventions

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

Group II: Arm I (standard of care ablation)Active Control3 Interventions

Patients undergo standard of care ablation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ablation Therapy

2006

Completed Phase 2

~80

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,681 Total Patients Enrolled

22 Trials studying Liver Cancer

9,411 Patients Enrolled for Liver Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,053 Total Patients Enrolled

104 Trials studying Liver Cancer

26,668 Patients Enrolled for Liver Cancer

BRUNO C ODISIOPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Ablation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04083378 — Phase 3

Liver Cancer Research Study Groups: Arm I (standard of care ablation), Arm II (standard of care ablation, software-aided imaging)

Liver Cancer Clinical Trial 2023: Ablation Therapy Highlights & Side Effects. Trial Name: NCT04083378 — Phase 3

Ablation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083378 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being researched in this clinical trial?

"That is accurate, the clinical trial is currently underway. Per information available on clinicaltrials.gov, the first posting was made on 1/10/2020 with the most recent update being 8/25/2021. They are looking for 100 individuals total to participate at 1 location."

Answered by AI

Is Ablation Therapy a high-risk treatment option?

"While Phase 2 trials offer less evidence than later stages in the development process, our team has assessed that there is enough data supporting the safety of ablation therapy to give it a score of 2."

Answered by AI

Are there still open slots for volunteers in this research project?

"Yes, this is an active clinical trial that has been open since January 10th, 2020 and was last updated on August 25th, 2021 according to the information available on clinicaltrials.gov"

Answered by AI

Recent research and studies

CardioVascular and Interventional RadiologyJournal

Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions

Lin, Yuan-Mao, Iwan Paolucci, Brian M. Anderson, Caleb S. O’Connor, Bastien Rigaud, Maria Briones-Dimayuga, Kyle A. Jones, Kristy K. Brock, Bryan M. Fellman, and Bruno C. Odisio. 2022. “Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions”. Cardiovascular and Interventional Radiology. Springer Science and Business Media LLC. doi:10.1007/s00270-022-03255-3.

clinicaltrials.govStudy

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

2020. "Software-Aided Imaging (Morfeus) for Confirming Tumor Coverage With Ablation in Patients With Liver Tumors, the COVER-ALL Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04083378.