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

Early Phase 1TerminatedNCT02374931

Vanderbilt-Ingram Cancer Center3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Deep Fibromatosis/Desmoid Tumor Familial Adenomatous Polyposis

Interventions

F-18 16 Alpha-FluoroestradiolDRUG

Undergo 18F-FES PET/CT

Positron Emission TomographyPROCEDURE

Undergo 18F-FES PET/CT

Computed TomographyPROCEDURE

Undergo 18F-FES PET/CT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: Initial visit, average within 24 hours of imaging

Secondary Outcomes

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.

Time frame: Within 4 weeks of imaging done at initial visit, day 1

Data from ClinicalTrials.gov

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