Feasibility Study to Treat Lung Cancer With the Permanently NCT03290534

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

Related Conditions & MeSH terms

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome