Feasibility Study for CivaSheet in Lung Cancer

This study is looking at a new way to treat lung cancer using a device called CivaSheet. CivaSheet delivers radiation directly to the tumor, similar to standard treatments but in a different setup. The goal is to see if CivaSheet can effectively treat lung cancer while reducing radiation exposure to important organs like your heart. We are looking for up to 40 participants who have non-small cell lung cancer (NSCLC) in the upper parts of their lungs, with a tumor size of 7 cm or less, and who are in clinical stage I or II. The main way we'll know if the treatment is successful is by checking how well the cancer is controlled in the treated area after one year. The current status of this study is unclear.

Study design
This is a feasibility study, meaning it's an early look at how well a new treatment works. It aims to enroll up to 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the cancer is controlled at one year after treatment.

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NCT03290534

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
CivaTech Oncology
~40 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:CivaSheet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local Control Rate at 1 year
Measured over 1 year
Lung Cancer
Lung Cancer Stage I
Lung Cancer Stage II
1 sites across 1 states
New York1

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Eligibility criteria

Inclusion

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
  • Local Control Rate at 1 year1 year

    The local control rate in the region irradiated by CivaSheet.