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Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01671163
First received: August 1, 2012
Last updated: March 13, 2013
Last verified: March 2013
History of Changes

August 1, 2012
March 13, 2013
July 2012
August 2015   (final data collection date for primary outcome measure)
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system. [ Time Frame: approximately one week ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01671163 on ClinicalTrials.gov Archive Site
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Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy
EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy

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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

All subjects who are currently scheduled to undergo fiducial placement at the University of Florida in Gainesville as medically indicated.
Cancer
Procedure: Endoscopic Ultrasound (EUS) for fiducial placement
Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist
Subjects requiring fiducial placement
Endoscopic Ultrasound (EUS) for fiducial placement
Intervention: Procedure: Endoscopic Ultrasound (EUS) for fiducial placement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Peter V Draganov, MD 352-273-9474 peter.draganov@medicine.ufl.edu
United States
 
NCT01671163
endoscopic fiducial placement, 326-2012
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Peter V Draganov, MD University of Florida
Principal Investigator: Robert Zlotecki, MD University of Florida
Principal Investigator: Disaya Chavalitdhamrong, MD University of Florida
University of Florida
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP