RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-03-13
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03290534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject signed inform consent
  2. * Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung
  3. * Pre-operative criteria
  4. * Lung nodule suspicious for NSCLC
  5. * Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen
  6. * Clinical stage I or Clinical stage II
  7. * Not pregnant or nursing
  8. * Negative pregnancy test in premenopausal women
  9. * Fertile patients must use effective contraception
  10. * More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kristy Perez, PhD
CONTACT
9193145515
kperez@civatechoncology.com

Principal Investigator

Abe Wu, MD
PRINCIPAL_INVESTIGATOR
MSKCC

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: CivaTech Oncology

  • Abe Wu, MD, PRINCIPAL_INVESTIGATOR, MSKCC

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

Study Start Date2019-03-13
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-03-13
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • wedge resection
  • sublobar resection
  • brachytherapy
  • CivaSheet
  • Pd-103
  • CivaTech Oncology
  • lung cancer
  • lung

Additional Relevant MeSH Terms

  • Lung Cancer
  • Lung Cancer Stage I
  • Lung Cancer Stage II