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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])
Patients with =< 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 3 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation
Must not have
Patients with uncorrectable coagulopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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
Select...
I am able to get out of my bed or chair and move around.
Select...
I have up to 3 liver tumors, each 1-3 cm, planned for a specific heat treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a blood clotting disorder that cannot be corrected.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Impact of software use on the minimal margins of ablated lesions properly covered by ablation on a three-dimensional analysis
Secondary study objectives
Complication rates
Intra-hepatic progression-free survival
Liver function
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,438 Total Patients Enrolled
22 Trials studying Liver Cancer
9,398 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,473 Total Patients Enrolled
104 Trials studying Liver Cancer
26,513 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
~18 spots leftby Dec 2025
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