Clinical Trial: 18F-FES PET/CT in Imaging Patients With Desmoid Tumors
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
Brief Summary: This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors. 18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.
Detailed Summary:
PRIMARY OBJECTIVES:
I. Establish the avidity of desmoid tumors on 18F-FES PET/CT imaging. II. Correlate 18F-FES PET avidity with degree of estrogen receptor (ER) expression by immunohistochemistry (IHC).
OUTLINE:
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
After completion of study, patients are followed up for 30 days.
Sponsor: Vanderbilt-Ingram Cancer Center
Current Primary Outcome: Standard uptake value (SUV) measured as percent injected dose per cc [ Time Frame: Initial visit, average within 24 hours of imaging ]
Original Primary Outcome: Same as current
Current Secondary Outcome: IHC staining intensity in tissue samples [ Time Frame: Within 4 weeks of imaging done at initial visit, day 1 ]
Original Secondary Outcome: Same as current
Information By: Vanderbilt-Ingram Cancer Center
Dates:
Date Received: February 16, 2015
Date Started: April 2015
Date Completion: December 2018
Last Updated: January 12, 2017
Last Verified: January 2017