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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II

Intervention / Treatment
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* Device: CivaSheet


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CivaSheet Directional LDR Brachytherapy<br>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. | Device: CivaSheet<br>* implanting CivaSheet for localized radiation dose delivery<br>* Other names: brachytherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control Rate at 1 year | The local control rate in the region irradiated by CivaSheet. | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wedge resection, sublobar resection, brachytherapy, CivaSheet, Pd-103, CivaTech Oncology, lung cancer, lung