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Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®

RECRUITINGPhase 2Sponsored by CivaTech Oncology
Actively Recruiting
PhasePhase 2
SponsorCivaTech Oncology
Started2019-03-13
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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: 18 Years+Healthy volunteers accepted
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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Conditions4

CancerLung CancerLung Cancer Stage ILung Cancer Stage II

Locations1 site

NYU Langone Health
New York, New York, 10016
Charles Kambourakis212-263-7102charles.kambourakis@nyulangone.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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