Recruiting
Phase 2

CivaSheet

Sponsor:

CivaTech Oncology

Code:

NCT03290534

Conditions

Lung Cancer

Lung Cancer Stage I

Lung Cancer Stage II

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CivaSheet

Study Details

Brief summary:

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.

Conditions

Lung Cancer

Lung Cancer Stage I

Lung Cancer Stage II

Study ID

NCT03290534

Start date

Mar 13, 2019

Status verified date

Feb, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

-

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CivaSheet Directional LDR Brachytherapy

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.

Interventions

CivaSheet

implanting CivaSheet for localized radiation dose delivery

Primary outcome measure

  • Local Control Rate at 1 year [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Charles Kambourakis

212-263-7102charles.kambourakis@nyulangone.org

Principal Investigator:

Michael Zervos, MD

More Information

Sponsor

CivaTech Oncology

Last update posted

Apr 4, 2025

Last verified

Feb, 2025

Keywords

  • wedge resection
  • sublobar resection
  • brachytherapy
  • CivaSheet
  • Pd-103
  • CivaTech Oncology
  • lung cancer
  • lung

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CivaTech Oncology on 2025-04-04.