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

CivaTech Oncology

Status and phase: Enrolling; Phase 2

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

Treatments: Device: CivaSheet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03290534

CT006

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

CivaSheet Directional LDR Brachytherapy

Experimental group

Description:

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.

Treatment:

Device: CivaSheet