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Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

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ClinicalTrials.gov Identifier: NCT01671163
Recruitment Status : Recruiting
First Posted : August 23, 2012
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cancer Procedure: Endoscopic Ultrasound (EUS) for fiducial placement

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
Study Start Date : July 2012
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V Draganov, MD University of Florida
Principal Investigator: Robert Zlotecki, MD University of Florida
More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01671163     History of Changes
Other Study ID Numbers: IRB201600243
326-2012 ( Other Identifier: University of Florida Institutional Review Board )
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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