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Microwave Ablation

Microwave Ablation for Lung Cancer

N/A

Recruiting

Led By Jason Beattie, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively

Participants must be at least 22 years old and able to provide consent

Must not have

Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor

Patients with coagulopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is being done to see if the AveCure Flexible Microwave Ablation Probe is effective in destroying cancerous lung nodules that are up to 3 c m in size.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, generally microwave ablation can cause pain at the site of treatment, bleeding into the chest cavity or airways, collapse of part of a lung (pneumothorax), damage to surrounding organs or structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am eligible for surgery to remove part of my lung.

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My lung cancer is in the early stages (Stage I or II) and involves a single nodule up to 3 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a blood clotting disorder.

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I cannot undergo a flexible bronchoscopy due to health reasons.

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I cannot undergo a bronchoscopy due to intolerance.

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I am currently COVID-19 positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological changes in the tumor tissue.

Rate of Planned Ablations.

Secondary study objectives

Histological changes in lung tissue outside the zone of predicted ablation.

Immune-histochemical changes in the tumor tissue.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULESExperimental Treatment1 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.

0 / 9Eligibility criteria met