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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment40 people
  • Recruiting US sites1
  • SponsorCivaTech Oncology
  • RegistryNCT03290534

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®: a one-minute explainerNCT032905341 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • CivaSheet (Device): implanting CivaSheet for localized radiation dose delivery

The study

Treatment groups

Na · Single Group · masking: None

CivaSheet Directional LDR Brachytherapy (Experimental)

FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

Goals

What the study measures

Main goals

  • Local Control Rate at 1 year (1 year)

Other goals

  • Freedom from regional or distant recurrence
  • Time to recurrence
  • Toxicity graded on CTCAE 4.0 Scale

Planned enrollment: 40 (estimated).

Where

Recruiting US sites

  • NYU Langone Health, New York, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 20, 2026. Public record; not medical advice.

For you, or someone you love

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