Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 lung-cancer
Started Mar 2019
Longer than P75 for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 4, 2025
February 1, 2025
7.7 years
September 18, 2017
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Control Rate at 1 year
The local control rate in the region irradiated by CivaSheet.
1 year
Secondary Outcomes (3)
Freedom from regional or distant recurrence
1 year
Time to recurrence
1 year
Toxicity graded on CTCAE 4.0 Scale
1 year
Study Arms (1)
CivaSheet Directional LDR Brachytherapy
EXPERIMENTALFDA 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.
Interventions
implanting CivaSheet for localized radiation dose delivery
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 25, 2017
Study Start
March 13, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
April 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share