Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

NCT01671163 | Terminated

• 2 other identifiers: IRB201600243326-2012
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Radiation therapy; Fiducial markers

Outcome Measures

Primary Outcomes (1)

• Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.

  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.

  approximately one week

Study Arms (1)

Subjects requiring fiducial placement

Endoscopic Ultrasound (EUS) for fiducial placement

Procedure: Endoscopic Ultrasound (EUS) for fiducial placement

Interventions

Endoscopic Ultrasound (EUS) for fiducial placement PROCEDURE

Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist

Subjects requiring fiducial placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects who are currently scheduled to undergo fiducial placement at the University of Florida in Gainesville as medically indicated.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida/Shands

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Peter V Draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Robert Zlotecki, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 23, 2012
• Study Start: July 1, 2012
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)