Cancer Clinical Trial
Official title:
EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
Verified date | August 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 18 |
Est. completion date | August 12, 2019 |
Est. primary completion date | August 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida/Shands | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system. | 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. |
approximately one week |
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