Computer Guided Microwave Liver Ablation

NCT07226869 | Recruiting DMC FDA Device

• 2 other identifiers: NES_2025_011R44CA287803-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

hepatocellular carcinoma; liver neoplasm; primary liver cancer; microwave ablation (MWA); percutaneous ablation; computer-assisted ablation; simulation-guided ablation; 3D ablation planning; treatment planning software; image-guided ablation; local tumor progression

Outcome Measures

Primary Outcomes (2)

• Local Tumor Progression

  Local Tumor Progression (LTP) is defined as the appearance of new or enlarging nodular or irregular arterial phase enhancement with washout at or within the edge of a previously ablated lesion after an earlier imaging study has demonstrated complete ablation (technical effectiveness). LTP is determined on serial contrast-enhanced CT or MRI according to LI-RADS treatment response criteria or equivalent institutional standards.

  Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months).

• Technical Effectiveness

  Technical Effectiveness is defined as complete ablation of all target tumor tissue, demonstrated by the absence of any nodular or irregular arterial phase enhancement within or along the margin of the ablation zone on the first post-ablation contrast-enhanced imaging study (CT or MRI). This assessment is performed approximately one month after the procedure. Imaging is interpreted according to LI-RADS treatment response criteria (LR-TR) or equivalent institutional criteria.

  1 month post-procedure

Study Arms (1)

Computerized Guidance

EXPERIMENTAL

Patients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance.

Device: Computer-Assisted Microwave Liver Ablation

Interventions

Computer-Assisted Microwave Liver Ablation DEVICE

Computer-assisted image-processing software used intraoperatively to assist in percutaneous thermal ablation. The software performs segmentation and registration of pre-procedural and intraprocedural imaging, and simulates the expected ablation zone based on probe position, applied energy, and adjacent vascular structures. The output is displayed in 3D multiplanar images to be used by the treating physician to assist in planning, targeting, and intraprocedural decision-making regarding adequacy of ablation coverage. After each ablation activation, the treating physician determines registration accuracy and decides whether any additional ablation is required, based on images of the software estimation of what tissues have and have not been treated.

Computerized Guidance

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior local therapy to the target lesion (ablation, TACE, SBRT, or resection) or to a lesion within 1 cm of the target lesion
• More than 5 hepatic lesions, or any lesion ineligible for technically complete ablation
• uncontrolled hepatic decompensation, including:
• o Persistent encephalopathy
• Uncorrectable coagulopathy or contraindication to percutaneous liver intervention
• Contraindication to contrast-enhanced imaging (e.g., severe CKD without dialysis, contrast allergy not correctable with premedication)
• Active systemic infection
• Pregnancy
• Inability to comply with follow-up imaging schedule

Sponsors & Collaborators

• NE Scientific INC: lead
• National Cancer Institute (NCI): collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Dartmouth HItchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Related Publications (2)

• Hoffer EK, Borsic A, Patel SD. Validation of Software for Patient-Specific Real-Time Simulation of Hepatic Radiofrequency Ablation. Acad Radiol. 2022 Oct;29(10):e219-e227. doi: 10.1016/j.acra.2021.12.018. Epub 2022 Jan 14.

  PMID: 35039220 BACKGROUND

• Hoffer EK, Drinane MC, Bhatnagar V, Mehta R, Munger DP, Borsic A. Radiofrequency ablation of hepatocellular carcinoma guided by real-time physics-based ablation simulation: a prospective study. Int J Hyperthermia. 2024;41(1):2331704. doi: 10.1080/02656736.2024.2331704. Epub 2024 Mar 19.

  PMID: 38503326 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Andrea Borsic, PHD

  NE Scientific INC

  STUDY DIRECTOR

Central Study Contacts

Eric Hoffer, MD

CONTACT

1 603 667 0283; hoffer@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Imaging outcomes will be assessed by independent radiologists blinded to intervention status
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: May 8, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 12 months after publication of the primary study results and continuing for a minimum of 5 years thereafter.
• Access Criteria: Qualified investigators affiliated with academic, research, or healthcare institutions. For research purposes consistent with the scientific aims of the original study or for meta-analyses addressing related clinical or technical questions. Study protocol, statistical analysis plan, and data dictionary will be available upon reasonable request. Requests for de-identified data may be submitted to the Principal Investigator (Dr. Eric Hoffer, Dartmouth-Hitchcock Medical Center) by email. Access will be granted following review of the request and execution of a data use agreement approved by the sponsor (NE Scientific, Inc.) and the Principal Investigator.

Locations

US (2)