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

Sponsor

CivaTech Oncology (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03290534

Collaborator

(none)

Enrollment

Locations

Arm

56.6

Anticipated Duration (Months)

13.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lung Cancer Stage I Lung Cancer Stage II	Device: CivaSheet	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 13, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CivaSheet Directional LDR Brachytherapy 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 implanting CivaSheet for localized radiation dose delivery Other Names: brachytherapy

Arm

Intervention/Treatment

Experimental: CivaSheet Directional LDR Brachytherapy

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

implanting CivaSheet for localized radiation dose delivery

Other Names:

brachytherapy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mission Hospital St Joesph	Mission Viejo	California	United States	92691
2	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10016
3	NYU Langone Health	New York	New York	United States	10016