Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
Overview
- Phase
- Early Phase 1
- Intervention
- F-18 16 Alpha-Fluoroestradiol
- Conditions
- Deep Fibromatosis/Desmoid Tumor
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Standard uptake value (SUV) measured as percent injected dose per cc
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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 Description
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.
Investigators
Ashish Patel
Principal Investigator
Vanderbilt-Ingram Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Patients with biopsy-proven extra-abdominal desmoid tumors
- •Not currently on estrogen medication for birth control, menopause, or other reason
- •No anti-estrogen therapy for desmoid tumor within the past 6 months
- •Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included
Exclusion Criteria
- •Pregnancy or nursing patients
- •Patients who do not wish to participate
Arms & Interventions
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Intervention: F-18 16 Alpha-Fluoroestradiol
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Intervention: Positron Emission Tomography
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Intervention: Computed Tomography
Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Intervention: Laboratory Biomarker Analysis
Outcomes
Primary Outcomes
Standard uptake value (SUV) measured as percent injected dose per cc
Time Frame: Initial visit, average within 24 hours of imaging
Data will be summarized graphically and numerically. Continuous variables (e.g. SUV) will be summarized using the mean, standard deviation, and a 5 number percentile summary set (minimum, p25, p50, p75, and maximum). The Spearman correlation statistic will be used to estimate the magnitude of a linear association between SUV and IHC measures. Ninety-five percent confidence intervals will be calculated for all point estimates.
Secondary Outcomes
- IHC staining intensity in tissue samples(Within 4 weeks of imaging done at initial visit, day 1)