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18F-FES PET/CT in Imaging Patients With Desmoid Tumors
study id #: NCT02374931
condition: Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis
status: Active, not recruitingpurpose:
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.
Radiation: F-18 16 Alpha-Fluoroestradiol
Procedure: Positron Emission Tomography
Procedure: Computed Tomography
Other: Laboratory Biomarker Analysis
start date: April 2015
estimated completion: December 2018
last updated: April 11, 2018
phase of development: Early Phase 1
size / enrollment: 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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).
Patients undergo 18F-FES PET/CT imaging over 30 minutes. After completion of study, patients are followed up for 30 days.
- Standard uptake value (SUV) measured as percent injected dose per cc [Time Frame: Initial visit, average within 24 hours of imaging] [Designated as safety issue: No]
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.
- IHC staining intensity in tissue samples [Time Frame: Within 4 weeks of imaging done at initial visit, day 1] [Designated as safety issue: No]
IHC staining intensity measured on an ordinal scale or dichotomized as positive or negative. Data will be summarized graphically and numerically. Categorical measures (e.g., IHC) will be summarized in frequency tables. 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.
- 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
- Demonstration of recent growth of tumor either by imaging or clinical assessment
- Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included
- Pregnancy or nursing patients
- Patients who do not wish to participate
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