Microwave Ablation for Lung Cancer

Overseen By Jason Beattie, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Coagulopathy, Electronic implants, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called microwave ablation to determine its effectiveness in destroying small lung cancer nodules (abnormal tissue growths) up to 3 cm in size. The AveCure Flexible Microwave Ablation Probe targets and treats the cancerous nodules. The trial includes individuals diagnosed with early-stage lung cancer who have a single nodule accessible through bronchoscopy (a procedure using a tube down the throat to view the lungs). Participants will undergo follow-up CT scans and surgery to evaluate the treatment's effectiveness. As an unphased trial, this study allows patients to contribute to pioneering research in lung cancer treatment.

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 team or your doctor.

What prior data suggests that the AveCure Flexible Microwave Ablation Probe is safe for treating lung nodules?

Research shows that the AveCure Flexible Microwave Ablation Probe is being tested for safety and practicality in treating lung nodules. Earlier studies examined the probe's safety in destroying cancerous tissue, and the results were promising, with no serious side effects directly linked to the procedure.

This treatment uses microwave energy to heat and destroy cancer cells and has been well-tolerated. Some patients experienced minor side effects, such as temporary pain or discomfort at the treatment site, but these effects are usually mild and manageable.

The focus on safety and practicality in studies suggests confidence in using this treatment for similar conditions. While more research is needed to confirm these findings, the current data is encouraging for those considering this treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AveCure Flexible Microwave Ablation Probe for lung cancer because it offers a minimally invasive approach to target and destroy cancerous lung nodules. Unlike traditional surgery or chemotherapy, this technique uses microwave energy to heat and ablate tumors, potentially reducing recovery time and side effects. Additionally, it allows precise treatment of small lung nodules up to 3 cm, which might lead to more effective outcomes and fewer complications. This novel approach could provide a new option for patients who are not ideal candidates for conventional treatments.

What evidence suggests that the AveCure Flexible Microwave Ablation Probe is effective for lung cancer?

Research shows that microwave ablation (MWA) is a promising treatment for lung cancer. One study found that MWA effectively destroys cancerous lung nodules up to 3 cm in size. This method uses heat from microwaves to kill cancer cells. Early results suggest that MWA can accurately target and remove tumors. In this trial, participants will receive treatment with the AveCure Flexible Microwave Ablation Probe, a potential tool against lung cancer. Patients who underwent this treatment showed a significant decrease in tumor size on follow-up scans. ^{1 2 3 5 6}

Who Is on the Research Team?

Jason Beattie, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 22 with Stage I-II primary lung cancer, specifically solitary nodules up to 3 cm. They must have a confirmed type of malignancy and be candidates for surgery. Excluded are those with nodules under 1 cm, prior treatments on the nodule, contraindications to bronchoscopy, significant comorbidities, electronic implants, coagulopathy issues or participation in other lung cancer studies.

Inclusion Criteria

My tumor can be reached and checked with a special lung biopsy technique.

I am 22 years old or older and can give my consent.

You need to have a biopsy that shows the type of tumor you have, and it needs to be a good sample for testing.

Exclusion Criteria

My targeted tumor has been treated with radiation or chemotherapy before surgery.

I have a blood clotting disorder.

I cannot undergo a flexible bronchoscopy due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA) to treat solitary pulmonary nodules up to 3cm.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT scan evaluations and pathological assessments.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AveCure Flexible Microwave Ablation Probe

Trial Overview The study tests the effectiveness of the AveCure Flexible Microwave Ablation Probe on destroying cancerous lung nodules up to 3 cm. It involves microwave ablation (MWA) using this probe through navigational bronchoscopy and cone beam CT scan confirmation during operation.

How Is the Trial Designed?

Group I: AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES Experimental Treatment 1 Intervention

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm. * CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure. * Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.

AveCure Flexible Microwave Ablation Probe is already approved in United States for the following indications:

Approved in United States as AveCure Flexible Microwave Ablation Probe for:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
• Coagulation and ablation of tissue in bone during surgical procedures
• Treatment of cancerous lung nodules up to 3 cm in size

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

MedWaves, Inc

Collaborator

Trials

2

Recruited

20+

Published Research Related to This Trial

Microwave ablation is emerging as a promising treatment for unresectable lung cancer, offering potential advantages over radiofrequency ablation, such as larger ablation zones and shorter heating times.

The study highlights a complication of microwave ablation, specifically bronchocutaneous fistula (BCF), and discusses various treatment options for BCF, emphasizing the importance of understanding device limitations as microwave ablation becomes more widely used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave lung ablation complicated by bronchocutaneous fistula: case report and literature review. Bui, JT., Gaba, RC., Knuttinen, MG., et al.[2021]

In a pilot study involving 13 patients with inoperable peripheral lung cancer, endobronchial microwave ablation using navigation bronchoscopy achieved a technical success rate of 100%, indicating that the procedure is feasible and can be performed effectively.

The treatment resulted in a complete ablation rate of 78.6% and a 2-year local control rate of 71.4%, with a median progression-free survival of 33 months, suggesting that this method can provide significant therapeutic benefits for patients who are not candidates for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. Xie, F., Chen, J., Jiang, Y., et al.[2022]

In a study of 66 patients with advanced lung cancer, combining microwave ablation (MWA) with systemic treatment significantly improved the overall response rate (ORR) to 63.6%, compared to 24.4% in the control group receiving only systemic treatment.

The combination therapy was safe, with only mild adverse events reported, and it resulted in longer progression-free survival (PFS) and overall survival (OS) times, indicating a lower risk of disease progression and death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical analysis of systemic chemotherapy combined with microwave ablation in the treatment of lung cancer. Feng, K., Lu, Y.[2022]

Microwave ablation is a safe and effective treatment for lung tumors, with a median time to tumor recurrence of 62 months and lower recurrence rates for tumors smaller than 3 cm.

The study found that larger tumors (greater than 3 cm) had higher odds of treatment failure and complications, highlighting the importance of tumor size in the success of microwave ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave Ablation for Lung Neoplasms: A Retrospective Analysis of Long-Term Results. Healey, TT., March, BT., Baird, G., et al.[2022]

The study demonstrated that flexible bronchoscopy-guided water-cooled microwave ablation (MWA) is both feasible and safe for treating peripheral lung cancer in porcine models, with no complications reported during the procedures.

Ablation successfully created coagulation necrosis in lung tissue, indicating effective treatment, and showed signs of tissue repair after 4 weeks, suggesting potential for MWA as a therapeutic option for lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible bronchoscopy-guided microwave ablation in peripheral porcine lung: a new minimally-invasive ablation. Yuan, HB., Wang, XY., Sun, JY., et al.[2022]

In a study of 231 patients with early-stage non-small cell lung cancer (NSCLC), those with tumors near bronchovascular bundles had lower local progression-free survival rates, indicating that tumor location significantly impacts treatment outcomes.

Achieving a specific ablation range during CT-guided microwave ablation may enhance local efficacy for tumors adjacent to bronchovascular bundles, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and local efficacy of computed tomography-guided microwave ablation for treating early-stage non-small cell lung cancer adjacent to bronchovascular bundles. Wang, J., Li, B., Zhang, L., et al.[2023]

The use of a novel three-dimensional visualization ablation planning system (3D-VAPS) in microwave ablation (MWA) for stage I non-small cell lung cancer (NSCLC) resulted in a 100% technical success rate and a 97.35% complete ablation rate three months post-procedure, indicating high efficacy.

The study reported no deaths during or within 30 days after the MWA procedure, and while complications such as pneumothorax and intrapulmonary hemorrhage occurred, the overall safety profile was deemed acceptable, suggesting that 3D-VAPS can help optimize the procedure and reduce risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and feasibility of three-dimensional visualization planning system for CT-guided microwave ablation of stage I NSCLC (diameter ≤2.5 cm): A pilot study. Hu, Y., Xue, G., Liang, X., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04006

AveCure Flexible Microwave Ablation Probe for Peripheral ... This clinical trial tests the effectiveness of the AveCure flexible microwave ablation probe using cone beam computed tomography (CBCT)-guided robotic assisted ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05281237/avecure-flexible-microwave-ablation-probe-for-lung-nodules

Avecure Flexible Microwave Ablation Probe For Lung ... This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/336601

Avecure Flexible Microwave Ablation Probe For Lung ... This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06105606

Feasibility of the AveCure Microwave Ablation Technology ... This research is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5179347/

CT-guided percutaneous microwave ablation of pulmonary ... The purpose of this retrospective study was to evaluate the preliminary results of safety and efficacy of MWA with a dynamic frequency range (902–928 MHz) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12551209/

Safety and feasibility of bronchoscopic microwave ablation ... Our primary objective is to evaluate the safety and feasibility of the AveCure 16 Gauge Flexible Microwave Ablation Probe (FMAP) and Medwaves ...