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Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

This study is currently recruiting participants.
Verified September 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671163
First Posted: August 23, 2012
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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:


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 ]

    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: October 2017
Estimated Primary Completion Date: October 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 1, 2012
First Posted: August 23, 2012
Last Update Posted: September 15, 2017
Last Verified: September 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