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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03290534
Other study ID # CT006
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 13, 2019
Est. completion date December 2025

Study information

Verified date September 2023
Source CivaTech Oncology
Contact Kristy Perez, PhD
Phone 9193145515
Email kperez@civatechoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
CivaSheet
implanting CivaSheet for localized radiation dose delivery

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
CivaTech Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Local Control Rate at 1 year The local control rate in the region irradiated by CivaSheet. 1 year
Secondary Freedom from regional or distant recurrence Control rate for recurrences outside the local area irradiated by CivaSheet. 1 year
Secondary Time to recurrence Time in months to any recurrence 1 year
Secondary Toxicity graded on CTCAE 4.0 Scale pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc. 1 year
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