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

Vanderbilt University Medical Center

Status and phase

Terminated

Early Phase 1

Conditions

Familial Adenomatous Polyposis

Deep Fibromatosis/Desmoid Tumor

Treatments

Procedure: Computed Tomography

Other: Laboratory Biomarker Analysis

Drug: F-18 16 Alpha-Fluoroestradiol

Procedure: Positron Emission Tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02374931

VICC SAR 1458 (Other Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

NCI-2015-00081 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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