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

Familial Adenomatous Polyposis Clinical Trial

Official title:

Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02374931
• Other study ID #: VICC SAR 1458
• Secondary ID: NCI-2015-00081VI
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Deep Fibromatosis/Desmoid Tumor
• Familial Adenomatous Polyposis
• Fibroma

Intervention

Drug:
• F-18 16 Alpha-Fluoroestradiol
Undergo 18F-FES PET/CT

Procedure:
• Positron Emission Tomography
Undergo 18F-FES PET/CT
• Computed Tomography
Undergo 18F-FES PET/CT

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Within 4 weeks of imaging done at initial visit, day 1

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial