Recruiting

Computer Guidance Software

Sponsor:

NE Scientific INC

Code:

NCT07226869

Conditions

Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Computer-Assisted Microwave Liver Ablation

Study Details

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)

Study ID

NCT07226869

Start date

May 8, 2026

Status verified date

May, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Computerized Guidance

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

Interventions

Computer-Assisted Microwave Liver Ablation

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.

Primary outcome measure

  • Local Tumor Progression [ Time Frame: Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months). ]
  • Technical Effectiveness [ Time Frame: 1 month post-procedure ]

Central Contacts and Locations

Central contacts

Eric Hoffer, MD

1 603 667 0283hoffer@hitchcock.org

Locations

Dartmouth HItchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Eric Hoffer, MD

6036670283hoffer@hitchcock.org

Andrea Borsic, PhD

6172949640aborsic@ne-scientific.com

Principal Investigator:

Eric Hoffer, MD

More Information

Sponsor

NE Scientific INC

Last update posted

May 11, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NE Scientific INC on 2026-05-11.