Back to resultsFeasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Primary Purpose
Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CivaSheet
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring wedge resection, sublobar resection, brachytherapy, CivaSheet, Pd-103, CivaTech Oncology, lung cancer, lung
Eligibility Criteria
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:
-
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CivaSheet Directional LDR Brachytherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Local Control Rate at 1 year
The local control rate in the region irradiated by CivaSheet.
Secondary Outcome Measures
Freedom from regional or distant recurrence
Control rate for recurrences outside the local area irradiated by CivaSheet.
Time to recurrence
Time in months to any recurrence
Toxicity graded on CTCAE 4.0 Scale
pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
Full Information
NCT ID
NCT03290534
First Posted
September 18, 2017
Last Updated
September 7, 2023
Sponsor
CivaTech Oncology
1. Study Identification
Unique Protocol Identification Number
NCT03290534
Brief Title
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Official Title
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CivaTech Oncology
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II
Keywords
wedge resection, sublobar resection, brachytherapy, CivaSheet, Pd-103, CivaTech Oncology, lung cancer, lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CivaSheet Directional LDR Brachytherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CivaSheet
Other Intervention Name(s)
brachytherapy
Intervention Description
implanting CivaSheet for localized radiation dose delivery
Primary Outcome Measure Information:
Title
Local Control Rate at 1 year
Description
The local control rate in the region irradiated by CivaSheet.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Freedom from regional or distant recurrence
Description
Control rate for recurrences outside the local area irradiated by CivaSheet.
Time Frame
1 year
Title
Time to recurrence
Description
Time in months to any recurrence
Time Frame
1 year
Title
Toxicity graded on CTCAE 4.0 Scale
Description
pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristy Perez, PhD
Phone
9193145515
Email
kperez@civatechoncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abe Wu, MD
Organizational Affiliation
MSKCC
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed El Zaeedi
First Name & Middle Initial & Last Name & Degree
Michael Zervos, MD
First Name & Middle Initial & Last Name & Degree
Benjamin Cooper, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
We'll reach out to this number within 24 hrs