Status:
RECRUITING
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Lead Sponsor:
CivaTech Oncology
Conditions:
Lung Cancer
Lung Cancer Stage I
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 c...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03290534
Start Date
March 13 2019
End Date
December 1 2027
Last Update
April 4 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016