Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

Terminated

• Conditions: Cancer
• Interventions: Procedure: Endoscopic Ultrasound (EUS) for fiducial placement

• Registration Number: NCT01671163
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-23
• Status Verified: 2019-08
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 18 years or older,
• Scheduled to undergo fiducial placement,
• Subject must be able to give informed consent

Exclusion Criteria

• Any contraindication to performing endoscopy,
• Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
• The subject is unable/unwilling to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects requiring fiducial placement	Endoscopic Ultrasound (EUS) for fiducial placement	Endoscopic Ultrasound (EUS) for fiducial placement

Primary Outcome Measures

Name	Time	Method
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.	approximately one week	The outcome measure for this study is to determine: 1. The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system,; 2. The accuracy of the fiducial delivery into the targeted tissue and; 3. to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan.; The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.

Trial Locations

Locations (1)

University of Florida/Shands; 🇺🇸 Gainesville, Florida, United States