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Recruiting

NCT Number: NCT03290534

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

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.

Recruiting

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Key information

Conditions

Lung Cancer Lung Cancer Stage I Lung Cancer Stage II Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Benjamin Cooper, MD

SUB_INVESTIGATOR

Charles Kambourakis

CONTACT

[email protected]

212-263-7102

Michael Zervos, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

CivaSheet

Device

implanting CivaSheet for localized radiation dose delivery

Other names: brachytherapy

Primary outcomes

  1. Local Control Rate at 1 year

    Time frame: 1 year

    The local control rate in the region irradiated by CivaSheet.

Secondary outcomes

  1. Freedom from regional or distant recurrence

    Time frame: 1 year

    Control rate for recurrences outside the local area irradiated by CivaSheet.

  2. Time to recurrence

    Time frame: 1 year

    Time in months to any recurrence

  3. Toxicity graded on CTCAE 4.0 Scale

    Time frame: 1 year

    pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.

Sponsors and collaborators

Lead sponsor

CivaTech Oncology

Industry

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2017
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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