Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Lung CancerLung Cancer Stage ILung Cancer Stage II
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject signed inform consent
Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung
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