Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
CivaTech Oncology
Summary
This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: \-
Interventions
- DeviceCivaSheet
implanting CivaSheet for localized radiation dose delivery
Location
- NYU Langone HealthNew York, New York