Computer-guided microwave ablation for liver cancer
Computer Guided Microwave Liver Ablation
This trial will test whether using a computer guidance program during microwave ablation helps doctors more completely treat liver cancer tumors in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | NE Scientific INC Industry-sponsored |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07226869 on ClinicalTrials.gov |
What this trial studies
This is a 24-month, two-center interventional study using Accublate computer guidance software during CT-guided percutaneous microwave ablation for hepatocellular carcinoma. The software provides 3D planning, interactive ablation-volume simulation, and real-time registration of probe position to help the operator visualize treated and untreated tumor. Physicians will perform microwave ablation with the software and outcomes will be compared to a historic control to measure incomplete treatments, 2-year local recurrence, and procedure-related complications. The study is being conducted at Massachusetts General Hospital and Dartmouth-Hitchcock Medical Center under IRB oversight.
Who should consider this trial
Good fit: Adults (≥18) with localized hepatocellular carcinoma eligible for curative intent percutaneous ablation, with up to 5 liver lesions (at least one 2–5 cm and no lesion >5 cm), ECOG 0–2, adequate coagulation, and ability to undergo CT/MRI and provide informed consent.
Not a fit: Patients with macrovascular invasion, extrahepatic metastases, more than five lesions, any lesion >5 cm, prior local therapy to the target lesion, or those not suitable for percutaneous ablation are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the guidance software could reduce incomplete ablations and lower local tumor recurrence, improving long-term tumor control after microwave ablation.
How similar studies have performed: A prior report using the same simulation software with radiofrequency ablation showed improved visualization associated with better outcomes, but application specifically to microwave ablation is less tested and is being examined here.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years, with life expectancy of at least 1 year 2. Diagnosis of hepatocellular carcinoma (HCC) confirmed by: * LI-RADS 5 imaging features or * Histopathology * Cirrhosis with AFP \> 400 3. 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 4. Tumor location deemed technically feasible for percutaneous ablation by the treating interventional radiologist 5. ECOG Performance Status 0-2 6. Adequate coagulation status, defined as: * Platelets ≥ 50,000/μL * INR ≤ 1.8 (or correctable) 7. Ability to undergo contrast-enhanced CT or MRI 8. Willingness and ability to provide informed consent Exclusion Criteria: 1. Prior local therapy to the target lesion (ablation, TACE, SBRT, or resection) or to a lesion within 1 cm of the target lesion 2. More than 5 hepatic lesions, or any lesion ineligible for technically complete ablation 3. uncontrolled hepatic decompensation, including: o Persistent encephalopathy 4. Uncorrectable coagulopathy or contraindication to percutaneous liver intervention 5. Contraindication to contrast-enhanced imaging (e.g., severe CKD without dialysis, contrast allergy not correctable with premedication) 6. Active systemic infection 7. Pregnancy 8. Inability to comply with follow-up imaging schedule
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Dartmouth HItchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Study coordinator: Eric Hoffer, MD
- Email: hoffer@hitchcock.org
- Phone: 1 603 667 0283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.