Hepatocellular Carcinoma (HCC)MWA SimNCT07226869
Computer Guided Microwave Liver Ablation
A study testing Computer-Assisted Microwave Liver Ablation in people with Hepatocellular Carcinoma (HCC), run by NE Scientific INC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Computer-Assisted Microwave Liver Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2026to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Active systemic infection
- Pregnancy
- Inability to comply with follow-up imaging schedule
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ronal Arellano, MD, 857-230-4195, rarellano@mgh.harvard.edu
Andrea Borsic, PhD, 6172949640, aborsic@ne-scientific.com
- Recruiting
Dartmouth HItchcock Medical Center
Lebanon, New Hampshire, 03756
Eric Hoffer, MD, 6036670283, hoffer@hitchcock.org
Andrea Borsic, PhD, 6172949640, aborsic@ne-scientific.com
About this study
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.
Read more
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)
Read the detailed description
Accublate (NE Scientific, Inc) is a computer-based tumor ablation guidance software that uniquely provides real-time simulation of expected ablation volumes. In a previously reported study of Radiofrequency Ablation, the improved visualization of treated versus untreated target tumor was associated with improved outcomes. This study examines clinical application of the simulation software for microwave ablation (MWA), which will be evaluated in a 24 month two-center clinical trial.
At Dartmouth Hitchcock Medical Center (DHMC), and at one other hospital, under IRB approval, adults referred from local Liver Tumor Boards for curative local treatment of up to four Hepatocellular Carcinoma (HCC) tumors of 2-5 cm diameter will be offered participation.
After providing informed consent, and meeting inclusion and exclusion criteria, the CT-guided MWA ablation will be performed, with the physician having the benefit of the graphical display of the Accublate MWA simulation guidance software. Prior to the ablation, the software provides 3D graphical display for planning, that includes the tumor, desired margin, and interactive model of the ablation probe and superimposed expected ablation volume at particular energy settings. During placement, the software permits registration of updated image of the actual probe position to original image of the segmented tumor, and with the interactive ablation volume settings, allows assessment of adequacy of targeting. After each activation of the ablation, the calculated simulated ablation volume is provided to indicate what tissues have, and have not, been ablated. These 3D views then provide guidance for intraprocedural adjustments to ensure target coverage by overlapping ablations, if indicated.
Patients are routinely admitted for overnight observation and receive IV pain and nausea medication if needed. One month after the ablation, patients will have a follow-up outpatient contrast-enhanced abdominal CT, and from these images, the rate of complete ablation (Technical Efficacy) will be determined. Additionally, patients will be followed at 3 month intervals for 24 months after the ablation to detect any complications, tumor recurrence (Local Tumor Progression), and survival.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Computer-Assisted Microwave Liver Ablation
- 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
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Microwave Liver AblationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Guidance | Experimental | Patients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance. Receives: Device: Computer-Assisted Microwave Liver Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start8 May 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NE Scientific INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Dartmouth-Hitchcock Medical Center, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Andrea Borsic, PHD, Study director, NE Scientific INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226869
- Sponsor's protocol ID
- NES_2025_01
- Other IDs
- 1R44CA287803-01
- Acronym
- MWA Sim
- Status last verified
- May 2026
- First submitted
- 7 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the published results, including key clinical, imaging, and procedural variables relevant to study outcomes.
Publications
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.
PubMed 35039220Hoffer 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.
PubMed 38503326
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Microwave Liver Ablation
- ClinicalTrials.gov ID
- NCT07226869
- Acronym / sponsor ID
- MWA Sim / NES_2025_01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- NE Scientific INCIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Dartmouth-Hitchcock Medical Center, Massachusetts General Hospital
- Study start
- 8 May 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Accublate (NE Scientific, Inc) is a computer-based tumor ablation guidance software that uniquely provides real-time simulation of expected ablation volumes. In a previously reported study of Radiofrequency Ablation, the improved visualization of treated versus untreated target tumor was associated with improved outcomes. This study examines clinical application of the simulation software for microwave ablation (MWA), which will be evaluated in a 24 month two-center clinical trial.
At Dartmouth Hitchcock Medical Center (DHMC), and at one other hospital, under IRB approval, adults referred from local Liver Tumor Boards for curative local treatment of up to four Hepatocellular Carcinoma (HCC) tumors of 2-5 cm diameter will be offered participation.
After providing informed consent, and meeting inclusion and exclusion criteria, the CT-guided MWA ablation will be performed, with the physician having the benefit of the graphical display of the Accublate MWA simulation guidance software. Prior to the ablation, the software provides 3D graphical display for planning, that includes the tumor, desired margin, and interactive model of the ablation probe and superimposed expected ablation volume at particular energy settings. During placement, the software permits registration of updated image of the actual probe position to original image of the segmented tumor, and with the interactive ablation volume settings, allows assessment of adequacy of targeting. After each activation of the ablation, the calculated simulated ablation volume is provided to indicate what tissues have, and have not, been ablated. These 3D views then provide guidance for intraprocedural adjustments to ensure target coverage by overlapping ablations, if indicated.
Patients are routinely admitted for overnight observation and receive IV pain and nausea medication if needed. One month after the ablation, patients will have a follow-up outpatient contrast-enhanced abdominal CT, and from these images, the rate of complete ablation (Technical Efficacy) will be determined. Additionally, patients will be followed at 3 month intervals for 24 months after the ablation to detect any complications, tumor recurrence (Local Tumor Progression), and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized Guidance | Experimental | Device: Computer-Assisted Microwave Liver AblationPatients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years, with life expectancy of at least 1 year
- Diagnosis of hepatocellular carcinoma (HCC) confirmed by:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Assisted Microwave Liver AblationComputer-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. | Device | Computerized Guidance |
Primary outcome
Local Tumor Progression
Time frame: Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months).
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.
Technical Effectiveness
Time frame: 1 month post-procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 35039220Hoffer 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.
- Background: PubMed 38503326Hoffer 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the published results, including key clinical, imaging, and procedural variables relevant to study outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Borsic, PHD study director
NE Scientific INC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Microwave Liver Ablation in people with Hepatocellular Carcinoma (HCC), run by NE Scientific INC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Hoffer, MD (1 603 667 0283, hoffer@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Progression (time frame: Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07226869, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.