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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
  Purpose

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.


Condition Intervention
Cancer
 Procedure: Endoscopic Ultrasound (EUS) for fiducial placement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects requiring fiducial placement
Endoscopic Ultrasound (EUS) for fiducial placement
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671163

Contacts
Contact: Peter V Draganov, MD 352-273-9474 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
University of Florida/Shands Recruiting
Gainesville, Florida, United States, 32610
Contact: Peter V Draganov, MD     352-273-9400     peter.draganov@medicine.ufl.edu    
Principal Investigator: Peter V Draganov, MD            
Principal Investigator: Robert Zlotecki, MD            
Principal Investigator: Disaya Chavalitdhamrong, MD            
Sub-Investigator: Shailendra Chauhan, MD            
Sub-Investigator: Mihir Wagh, MD            
Sponsors and Collaborators
University of Florida
Investigators
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
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01671163     History of Changes
Other Study ID Numbers: endoscopic fiducial placement, 326-2012
Study First Received: August 1, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Cancer
Radiation therapy
Fiducial markers

ClinicalTrials.gov processed this record on June 17, 2013