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NCT03290534 | RECRUITING | Lung Cancer

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

CivaTech Oncology

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

Lung Cancer

Lung Cancer Stage I

Lung Cancer Stage II

Intervention/treatment

CivaSheet

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Actual Study Start Date : 2019-03-13
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • -
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®

Location Details

NCT03290534

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016