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RecruitingInterventionalPhase 2
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
NCT ID: NCT03290534Sponsor: CivaTech OncologyLast updated: 2025-04-04
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.
Arms & interventions
- DeviceCivaSheet
implanting CivaSheet for localized radiation dose delivery
Outcome measures
Primary
Local Control Rate at 1 year
The local control rate in the region irradiated by CivaSheet.
Time frame: 1 year
Secondary
Freedom from regional or distant recurrence
Time frame: 1 year
Time to recurrence
Time frame: 1 year
Toxicity graded on CTCAE 4.0 Scale
Time frame: 1 year
Eligibility criteria
Sex: AllAge: 18 Years and olderHealthy 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:
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Study locations (1)
NYU Langone Health
New York, New York, 10016
Michael Zervos, MD · Principal Investigator
Benjamin Cooper, MD · Sub Investigator