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
• Interventions: Device: CivaSheet

• 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

Arm && Interventions

Group	Intervention	Description
CivaSheet Directional LDR Brachytherapy	CivaSheet	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.

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