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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00081 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICC SAR 1458 | Other Identifier | Vanderbilt-Ingram Cancer Center | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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PI left institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-FES PET/CT) | Experimental | Patients undergo 18F-FES PET/CT imaging over 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 16 Alpha-Fluoroestradiol | Drug | Undergo 18F-FES PET/CT |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashish Patel, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| ID | Term |
|---|---|
| D018222 | Desmoid Tumors |
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Positron Emission Tomography | Procedure | Undergo 18F-FES PET/CT |
|
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| Computed Tomography | Procedure | Undergo 18F-FES PET/CT |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Within 4 weeks of imaging done at initial visit, day 1 |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |