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

Who is this study for? Patients with lung cancer
What treatments are being studied? CivaSheet
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Time Frame
Start Date: 2019-03-13
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
Experimental: CivaSheet Directional LDR Brachytherapy
FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
Authors
Abe Wu
Related Therapeutic Areas
Sponsors
Leads: CivaTech Oncology

This content was sourced from clinicaltrials.gov

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