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

NCT03290534 · tracked via the Priya Life Science USA tracker

Sponsor

CivaTech Oncology

Phase

Phase 2

Started

2019-03-13

Last updated

2025-04-04

Condition(s) studied

Lung CancerLung Cancer Stage ILung Cancer Stage II

Investigational drug(s) / intervention(s)

CivaSheet

CivaSheet: implanting CivaSheet for localized radiation dose delivery

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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: \-

Primary outcome measure(s)

Local Control Rate at 1 year — 1 year
The local control rate in the region irradiated by CivaSheet.

Trial sites (1)

Facility	City	Region	Status
NYU Langone Health	New York	New York	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03290534 on ClinicalTrials.gov ↗ ← All trials in the USA