Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using a new device to treat lung cancer with targeted radiation

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

Run by CivaTech Oncology · NCT03290534 · Data updated 2026-11-12

This study is testing a new device that delivers targeted radiation to treat lung cancer in the upper lobes of the lungs while trying to protect nearby healthy tissues.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorCivaTech Oncology
Industry-sponsored
Drugs / interventionsradiation
Locations1 site (New York, New York)
StatusRecruiting
StartedMarch 13, 2019
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedOctober 21, 2026
Trial IDNCT03290534 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with suspected or proven non-small cell lung cancer in the upper lobes, with tumors measuring 7 cm or less.

Probably not a fit

Patients with advanced lung cancer beyond stage II or those with other significant health issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study evaluates the effectiveness of the CivaSheet, a brachytherapy device that uses palladium-103, in treating non-small cell lung cancer (NSCLC) located in the upper lobes of the lungs. The approach aims to deliver a therapeutic radiation dose to cancerous tissues while minimizing exposure to surrounding critical structures, such as the heart. Patients with lung nodules suspicious for NSCLC and specific size criteria will be included in the study. The goal is to assess the device's safety and efficacy in a clinical setting.

Why it matters

Potential benefit: If successful, this treatment could provide a more targeted and safer radiation therapy option for lung cancer patients.

How similar studies have gone: While this approach is innovative, similar studies using brachytherapy for lung cancer have shown promise, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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:

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Where it's running

  • NYU Langone Health
    New York, New York, United States
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.