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

Last updated: April 2, 2025
Sponsor: CivaTech Oncology
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Non-small Cell Lung Cancer

Cancer

Treatment

CivaSheet

Clinical Study ID

NCT03290534
CT006
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject signed inform consent

  • Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of theleft 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 orin-situ cancer

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: CivaSheet
Phase: 2
Study Start date:
March 13, 2019
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Mission Hospital St Joesph

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health

    New York City, New York 10016
    United States

    Site Not Available

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