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

NCT ID: NCT02374931

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Deep Fibromatosis/Desmoid Tumor Familial Adenomatous Polyposis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (18F-FES PET/CT)

Patients undergo 18F-FES PET/CT imaging over 30 minutes.

Group Type EXPERIMENTAL

F-18 16 Alpha-Fluoroestradiol

Intervention Type DRUG

Undergo 18F-FES PET/CT

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo 18F-FES PET/CT

Computed Tomography

Intervention Type PROCEDURE

Undergo 18F-FES PET/CT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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F-18 16 Alpha-Fluoroestradiol

Undergo 18F-FES PET/CT

Intervention Type DRUG

Positron Emission Tomography

Undergo 18F-FES PET/CT

Intervention Type PROCEDURE

Computed Tomography

Undergo 18F-FES PET/CT

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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16 alpha-fluroestradiol-17 beta F-18 FES FES Fluorine-18 16 alpha-fluoroestradiol Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan CAT CAT Scan CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Ashish Patel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashish Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

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NCI-2015-00081

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC SAR 1458

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC SAR 1458

Identifier Type: -

Identifier Source: org_study_id

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