18F-FES PET/CT in Imaging Patients With Desmoid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors

Conditions
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Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis

Intervention / Treatment
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* Drug: F-18 16 Alpha-Fluoroestradiol
* Procedure: Positron Emission Tomography
* Procedure: Computed Tomography
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (18F-FES PET/CT)<br>Patients undergo 18F-FES PET/CT imaging over 30 minutes. | Drug: F-18 16 Alpha-Fluoroestradiol<br>* Undergo 18F-FES PET/CT<br>* Other names: Fluorine-18 16 alpha-fluoroestradiol;Procedure: Positron Emission Tomography<br>* Undergo 18F-FES PET/CT<br>* Other names: Positron Emission Tomography Scan;Procedure: Computed Tomography<br>* Undergo 18F-FES PET/CT<br>* Other names: CT;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard uptake value (SUV) measured as percent injected dose per cc | 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. | Initial visit, average within 24 hours of imaging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IHC staining intensity in tissue samples | 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. | Within 4 weeks of imaging done at initial visit, day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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desmoid, FES-PET, aggressive fibromatosis