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

Phase 2

Recruiting

• Conditions: Lung Cancer Stage II; Lung Cancer; Lung Cancer Stage I

• Registration Number: NCT03290534
• Lead Sponsor: CivaTech Oncology

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2019-03-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Freedom from regional or distant recurrence	1 year	Control rate for recurrences outside the local area irradiated by CivaSheet.
Toxicity graded on CTCAE 4.0 Scale	1 year	pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
Time to recurrence	1 year	Time in months to any recurrence

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States