Actively Recruiting
Computer Guided Microwave Liver Ablation
Led by NE Scientific INC · Updated on 2026-05-11
84
Participants Needed
2
Research Sites
198 weeks
Total Duration
On this page
Sponsors
N
NE Scientific INC
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Computer Guided Microwave Liver Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with a life expectancy of at least 1 year
- Confirmed diagnosis of hepatocellular carcinoma (HCC) by LI-RADS 5 imaging, histopathology, or cirrhosis with AFP > 400
- Localized disease without macrovascular invasion or extrahepatic metastasis
- Up to 5 liver lesions with at least one lesion between 2 and 5 cm and none larger than 5 cm
- Tumor location suitable for percutaneous ablation as determined by the treating radiologist
- ECOG Performance Status of 0 to 2
- Adequate blood clotting function with platelets ≥ 50,000/μL and INR ≤ 1.8 (or correctable)
- Ability to undergo contrast-enhanced CT or MRI
- Willingness and ability to provide informed consent
You will not qualify if you...
- Prior local treatment to the target lesion or a lesion within 1 cm of the target (including ablation, TACE, SBRT, or surgery)
- More than 5 liver lesions or any lesion unsuitable for complete ablation
- Uncontrolled liver failure including persistent encephalopathy
- Uncorrectable bleeding problems or contraindications to percutaneous liver procedures
- Contraindications to contrast-enhanced imaging (e.g., severe kidney disease without dialysis, uncorrectable contrast allergy)
- Active systemic infection
- Pregnancy
- Inability to comply with the required follow-up imaging schedule
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
2
Dartmouth HItchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
E
Eric Hoffer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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