NCT03290534PHASE2Recruiting
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
CivaTech Oncology
Start Date
3/13/2019
Completion Date
12/1/2027
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 Criteria
Age Range: 18 years to No maximum
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:
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Interventions
DEVICE
CivaSheet
Conditions
Lung CancerLung Cancer Stage ILung Cancer Stage II
Locations
NYU Langone Health
New York, New York 10016
United States