Lung CancerCancerLungs and breathingDevicePhase 2
What this study is
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.
What's being tested
- CivaSheet
Intervention · DEVICE
implanting CivaSheet for localized radiation dose delivery
Study details
- Sponsor
- CivaTech Oncology
- Conditions
- Lung Cancer · Lung Cancer Stage I · Lung Cancer Stage II
- Enrolling
- 40 people
- Starts
- 2019-03-13
- Est. completion
- 2027-12
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openNYU Langone Health
New York, New York, United States
- Charles Kambourakis · Contact212-263-7102charles.kambourakis@nyulangone.org
- Michael Zervos, MD · Principal investigator
- Benjamin Cooper, MD · Sub-investigator
Recruiting
Study team
Sponsor
CivaTech Oncology
Study ID CT006
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.