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

September 7, 2023 updated by: CivaTech Oncology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Mohamed El Zaeedi
        • Sub-Investigator:
          • Benjamin Cooper, MD
        • Principal Investigator:
          • Michael Zervos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control Rate at 1 year
Time Frame: 1 year
The local control rate in the region irradiated by CivaSheet.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from regional or distant recurrence
Time Frame: 1 year
Control rate for recurrences outside the local area irradiated by CivaSheet.
1 year
Time to recurrence
Time Frame: 1 year
Time in months to any recurrence
1 year
Toxicity graded on CTCAE 4.0 Scale
Time Frame: 1 year
pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CivaTech Oncology

Investigators

  • Principal Investigator: Abe Wu, MD, MSKCC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on CivaSheet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe