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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03290534
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
CivaTech Oncology

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Cancer Stage I Lung Cancer Stage II Device: CivaSheet Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Device: CivaSheet
implanting CivaSheet for localized radiation dose delivery
Other Name: brachytherapy

Primary Outcome Measures :
  1. Local Control Rate at 1 year [ Time Frame: 1 year ]
    The local control rate in the region irradiated by CivaSheet.

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03290534

Contact: Carra Castagnero 9193145515
Contact: Kristy Perez, PhD 6789545744

Sponsors and Collaborators
CivaTech Oncology
Principal Investigator: Abe Wu, MD MSKCC

Responsible Party: CivaTech Oncology Identifier: NCT03290534     History of Changes
Other Study ID Numbers: CT006
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by CivaTech Oncology:
wedge resection
sublobar resection
CivaTech Oncology
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases