Computer-Assisted Microwave Ablation for Liver Cancer

(MWA Sim Trial)

Overseen By Eric Hoffer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NE Scientific INC

Disqualifiers: Prior local therapy, >5 lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new computer guidance software to determine if it helps doctors better target liver tumors during microwave ablation, a minimally invasive procedure using heat to destroy cancer cells. The software enables doctors to identify treated and untreated tumor areas, potentially reducing cancer recurrence and complications. Suitable candidates include those with liver cancer (specifically hepatocellular carcinoma) that has not spread beyond the liver and who can safely undergo imaging tests like CT or MRI scans. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future liver cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this computer guidance software is safe for liver tumor ablation?

Research has shown that microwave ablation (MWA) for liver tumors is generally safe and well-tolerated. In one study, the treatment was effective for 93% of patients, with only 2.7% experiencing major complications. Another report found complications in about 10% of patients, but most were not serious. This indicates that while some risks exist, they are uncommon. The treatment's successful use in many patients supports its safety for liver tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Computer-Assisted Microwave Ablation for liver cancer because it uses advanced computerized guidance to precisely target tumors. Unlike traditional methods like surgical resection or radiofrequency ablation, this technique leverages computer technology to enhance accuracy, potentially reducing damage to surrounding healthy tissues. This precision may lead to better outcomes, fewer complications, and a quicker recovery for patients.

What evidence suggests that this computer-assisted microwave ablation is effective for liver cancer?

Research has shown that microwave ablation effectively treats small liver tumors, successfully removing over 85% of them. One study found that 97.4% of tumors were completely destroyed using this method, with only minor side effects in a few patients. In this trial, participants will undergo liver cancer microwave ablation under computerized guidance. This guidance helps doctors precisely target the treated areas of the tumor, potentially lowering the chances of recurrence and reducing the number of treatments needed. ^{3 4 6 7 8}

Who Is on the Research Team?

Andrea Borsic, PHD

Principal Investigator

NE Scientific INC

Are You a Good Fit for This Trial?

This trial is for adults with liver cancer who are candidates for a procedure called microwave ablation. It's not clear what specific conditions exclude someone from participating, but typically, patients with certain health issues or those who can't follow the study protocol might be excluded.

Inclusion Criteria

Ability to undergo contrast-enhanced CT or MRI

I can take care of myself and perform daily activities.

I am 18 or older and expected to live at least another year.

Exclusion Criteria

Pregnancy

Inability to comply with follow-up imaging schedule

I cannot have imaging tests that use contrast dye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo CT-guided microwave ablation treatment of a liver tumor using computer-assisted simulation

1 day

1 visit (in-person)

Initial Follow-up

Participants have a follow-up outpatient contrast-enhanced abdominal CT to determine the rate of complete ablation (Technical Efficacy)

1 month

1 visit (in-person)

Long-term Follow-up

Participants are monitored for complications, tumor recurrence, and survival at 3-month intervals

24 months

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Computer-Assisted Microwave Liver Ablation

Trial Overview The trial tests if using computer guidance software during microwave ablation improves treatment success. The software helps visualize tumor treatment progress in real-time. Outcomes like complete tumor treatment and local recurrence rates at 2 years will be compared to past data without the software.

How Is the Trial Designed?

Group I: Computerized Guidance Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

NE Scientific INC

Lead Sponsor

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226869

NCT07226869 | Computer Guided Microwave Liver Ablation 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8616542/

On Efficacy of Microwave Ablation in the Thermal Treatment of ... The success rate for completely eliminating small liver tumors in patients treated with microwave ablation is greater than 85%.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1687850725006727

Efficacy analysis of ultrasound-guided percutaneous ... Results showed that the MWA group had significantly shorter hospital stays and less liver function impairment postoperatively, with comparable complication ...

4. mdpi.com mdpi.com/2072-6694/16/24/4211

The Efficacy and Safety of a Microwave Ablation System ... A primary technique efficacy of 97.4% was achieved, with complete ablation in 75 out of 77 tumors. Complications occurred in 10% of patients, with only 4% ...

5. nature.com nature.com/articles/s41598-021-03802-x

Microwave versus radiofrequency ablation for the treatment ... This randomized phase 2 clinical trial compares the effectiveness of MWA and RFA as well as morphology of corresponding ablation zones.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4356920/

Clinical outcome of medium-sized hepatocellular ... The estimated technical effectiveness rate was 93% in 182 patients. The major complication rate was 2.7% (5/182), including liver abscess in 4 cases, and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1051044325000478

Safety and Effectiveness of Microwave Ablation of Liver ... This NOLA summary reports on the safety and effectiveness of the initial set of 615 patients treated with MWA for primary and secondary hepatic malignant tumors ...

8. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.2513081740

Malignant Liver Tumors: Treatment with Percutaneous ... Conclusion: MW ablation is a well-tolerated technique with an acceptably low rate of major complications for treatment of malignant liver tumors ...