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Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
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.
Conditions:
🦠 Lung Cancer 🦠 Lung Cancer Stage I 🦠 Lung Cancer Stage II
🗓️ Study Start (Actual) 13 March 2019
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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:

    • -
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 September 2017
  • First Submitted that Met QC Criteria 20 September 2017
  • First Posted 25 September 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 September 2023
  • Last Update Posted 11 September 2023
  • Last Verified September 2023
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