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

Early Phase 1

Terminated

• Conditions: Deep Fibromatosis/Desmoid Tumor; Familial Adenomatous Polyposis
• Interventions: Drug: F-18 16 Alpha-Fluoroestradiol; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02374931
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-03-02
• Study Start: 2015-04
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F-FES PET/CT)	F-18 16 Alpha-Fluoroestradiol	Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Diagnostic (18F-FES PET/CT)	Positron Emission Tomography	Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Diagnostic (18F-FES PET/CT)	Computed Tomography	Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Diagnostic (18F-FES PET/CT)	Laboratory Biomarker Analysis	Patients undergo 18F-FES PET/CT imaging over 30 minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States