18F-FES PET/CT in Imaging Patients With Desmoid Tumors
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ClinicalTrials.gov Identifier: NCT02374931 |
Recruitment Status
:
Active, not recruiting
First Posted
: March 2, 2015
Last Update Posted
: April 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Deep Fibromatosis/Desmoid Tumor Familial Adenomatous Polyposis | Drug: F-18 16 Alpha-Fluoroestradiol Procedure: Positron Emission Tomography Procedure: Computed Tomography Other: Laboratory Biomarker Analysis | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | July 2017 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
|
Drug: F-18 16 Alpha-Fluoroestradiol
Undergo 18F-FES PET/CT
Other Names:
Procedure: Positron Emission Tomography
Undergo 18F-FES PET/CT
Other Names:
Procedure: Computed Tomography
Undergo 18F-FES PET/CT
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
|
- 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.
- IHC staining intensity in tissue samples [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374931
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Katherine Hartley, MD | Vanderbilt-Ingram Cancer Center |
Additional Information:
Responsible Party: | Katherine Hartley, Principal Investigator, Vanderbilt-Ingram Cancer Center |
ClinicalTrials.gov Identifier: | NCT02374931 History of Changes |
Other Study ID Numbers: |
VICC SAR 1458 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 ) |
First Posted: | March 2, 2015 Key Record Dates |
Last Update Posted: | April 11, 2018 |
Last Verified: | April 2018 |
Keywords provided by Katherine Hartley, Vanderbilt-Ingram Cancer Center:
desmoid FES-PET aggressive fibromatosis |
Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Adenomatous Polyposis Coli Fibromatosis, Aggressive |
Fibroma Adenomatous Polyps Adenoma Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Polyposis Genetic Diseases, Inborn Estradiol Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |