Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Recruiting · NCT03290534 · Interventional (participants receive a specific treatment) · Lead sponsor: CivaTech Oncology
View the official record on ClinicalTrials.gov →Interventions studied
CivaSheet
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- NYU Langone Health - New York, New York, United States