EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
18 Years
N/A
Both
Cancer
Trial Information
EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
Outcome Description:
The outcome measure for this study is to determine: The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system, The accuracy of the fiducial delivery into the targeted tissue and 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.
Outcome Time Frame:
approximately one week
Safety Issue:
No
Principal Investigator
Peter V Draganov, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida
Authority:
United States: Institutional Review Board
Study ID:
endoscopic fiducial placement
NCT ID:
NCT01671163
Start Date:
July 2012
Completion Date:
August 2015
Related Keywords:
- Cancer
- Cancer
- Radiation therapy
- Fiducial markers
Name | Location |
|---|---|
| University of Florida/Shands | Gainesville, Florida 32610 |
