Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis
Conditions
Keywords
desmoid, FES-PET, aggressive fibromatosis
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.
Interventions
Undergo 18F-FES PET/CT
PROCEDUREPositron Emission Tomography
Undergo 18F-FES PET/CT
PROCEDUREComputed Tomography
Undergo 18F-FES PET/CT
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard uptake value (SUV) measured as percent injected dose per cc | 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
| Measure | Time frame | Description |
|---|---|---|
| IHC staining intensity in tissue samples | Within 4 weeks of imaging done at initial visit, day 1 | 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. |
Countries
United States
Outcome results
None listed