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

Sponsor: CivaTech Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03290534

Patient View

This feasibility study evaluates the CivaSheet, a brachytherapy device using palladium-103, for treating NSCLC in the upper lung lobes. Eligible participants include those with suspected or confirmed NSCLC, tumors ≤7 cm, and clinical stage I or II. The study excludes pregnant or nursing women and requires effective contraception for fertile patients. The intervention involves implanting CivaSheet for targeted radiation delivery.

Patient Parameters

Program Overview

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 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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.