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

Part of paid clinical trials in New York, New York.

Sponsor
CivaTech Oncology
Study ID
NCT03290534
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CivaSheet — DEVICE
    implanting CivaSheet for localized radiation dose delivery

Study Details

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.

Key Dates

Start date
Mar 13, 2019
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Local Control Rate at 1 year [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Charles Kambourakis
[email protected]
212-263-7102
Michael Zervos, MD (PRINCIPAL_INVESTIGATOR)
Benjamin Cooper, MD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
NYU Langone Health· New York, NY

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