Using a new device to treat lung cancer with targeted radiation
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
This study is testing a new device that delivers targeted radiation to treat lung cancer in the upper lobes of the lungs while trying to protect nearby healthy tissues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CivaTech Oncology Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03290534 on ClinicalTrials.gov |
What this trial studies
This feasibility study evaluates the effectiveness of the CivaSheet, a brachytherapy device that uses palladium-103, in treating non-small cell lung cancer (NSCLC) located in the upper lobes of the lungs. The approach aims to deliver a therapeutic radiation dose to cancerous tissues while minimizing exposure to surrounding critical structures, such as the heart. Patients with lung nodules suspicious for NSCLC and specific size criteria will be included in the study. The goal is to assess the device's safety and efficacy in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients with suspected or proven non-small cell lung cancer in the upper lobes, with tumors measuring 7 cm or less.
Not a fit: Patients with advanced lung cancer beyond stage II or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more targeted and safer radiation therapy option for lung cancer patients.
How similar studies have performed: While this approach is innovative, similar studies using brachytherapy for lung cancer have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject signed inform consent * Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung * Pre-operative criteria * Lung nodule suspicious for NSCLC * Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen * Clinical stage I or Clinical stage II * Not pregnant or nursing * Negative pregnancy test in premenopausal women * Fertile patients must use effective contraception * More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer Exclusion Criteria: \-
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.