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Computer Guided Microwave Liver Ablation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if the intraoperative use of a computer guidance software can improve the success of liver tumor ablation in adults. The employed software calculates and displays a simulation of the ablation such that the physician can visualize what portion of the target tumor has, and has not been treated at any point during the procedure. The main questions it aims to answer are: 1) Does the use of the computer guidance software reduce the number of times a tumor is incompletely treated. 2) Does the use of the computer guidance software reduce the rate of local tumor recurrence at 2 year follow-up? 3) Was there an increase or a decrease in medical problems for participants after a procedure where the guidance software was used? Researchers will compare liver tumor treatment using the computer guidance software with an historic control to see if the addition of the guidance software improved the outcomes after an ablation. Participants will: Undergo CT-guided microwave ablation treatment of a liver tumor using computer-assisted simulation. Visit the clinic at one month and then every 3 months for blood tests and a contrast-enhanced CT or MRI imaging study (as per standard of care)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Age ≥ 18 years, with life expectancy of at least 1 year

• Diagnosis of hepatocellular carcinoma (HCC) confirmed by:

‣ LI-RADS 5 imaging features or

⁃ Histopathology

⁃ Cirrhosis with AFP \> 400

• Localized disease without macrovascular invasion or extrahepatic metastasis, eligible for curative-intent percutaneous thermal ablation, defined as:

• o Up to 5 lesions with at least one lesion, 2 -5 cm, and no lesion \>5 cm diameter

• Tumor location deemed technically feasible for percutaneous ablation by the treating interventional radiologist

• ECOG Performance Status 0-2

• Adequate coagulation status, defined as:

‣ Platelets ≥ 50,000/μL

⁃ INR ≤ 1.8 (or correctable)

• Ability to undergo contrast-enhanced CT or MRI

• Willingness and ability to provide informed consent

Locations
United States
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
New Hampshire
Dartmouth HItchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Eric Hoffer, MD
hoffer@hitchcock.org
1 603 667 0283
Time Frame
Start Date: 2026-05-08
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 84
Treatments
Experimental: Computerized Guidance
Patients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance.
Related Therapeutic Areas
Sponsors
Leads: NE Scientific INC
Collaborators: Massachusetts General Hospital, Dartmouth-Hitchcock Medical Center, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov