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Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung

Lung Cancer Clinical Trial

Official title:
LCI-LUN-SBRT-002: Pilot Study of SGRT Alone vs. SGRT in Combination With Fiducials for Breath Hold SBRT Treatments of the Lung

Clinical Trial Summary

This is a pilot study designed to to provide data and experience comparing two different techniques of breath hold SBRT treatments. The first technique will include SGRT, but with the assistance of implanted fiducials. Subjects will be treated with a breath hold technique utilizing SGRT, but will also be imaged during treatment with fiducial match. The second technique will utilize SGRT for breath hold treatments without the assistance of implanted fiducials/continuous imaging.

Clinical Trial Description

The study's primary objective is estimate the incidence of SBRT and fiducial-related pulmonary toxicities for subjects treated with SBRT who have tumors that move ≥ 1 cm in 3 different cohorts: 1) free breathing with SGRT 2) breath hold utilizing SGRT only; 3) breath hold utilizing SGRT in combination with implanted fiducials. Secondary objectives also include Estimate reliability of gated SBRT treatments utilizing SGRT vs. SGRT with fiducials estimating local control for SBRT in subjects treated in the three different cohorts, estimating overall survival, and evaluating quality of life. A safety objective of estimating acute and long-term grade 2 or higher non-hematologic toxicities attributed to SBRT/fiducial implantation in subjects treated in the three different cohorts will also be explored. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04060927
Study type Interventional
Source Wake Forest University Health Sciences
Contact Jenna Gregory, RN
Phone 704-403-1520
Email Jenna.Gregory@atriumhealth.org
Status Recruiting
Phase N/A
Start date September 25, 2019
Completion date December 2024
View Details
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