This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Katherine Hartley, Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Katherine Hartley, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT02374931
First received: February 16, 2015
Last updated: January 12, 2017
Last verified: January 2017
February 16, 2015
January 12, 2017
April 2015
December 2018   (Final data collection date for primary outcome measure)
Standard uptake value (SUV) measured as percent injected dose per cc [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT02374931 on ClinicalTrials.gov Archive Site
IHC staining intensity in tissue samples [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
18F-FES PET/CT in Imaging Patients With Desmoid Tumors
Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Deep Fibromatosis/Desmoid Tumor
  • Familial Adenomatous Polyposis
  • Radiation: F-18 16 Alpha-Fluoroestradiol
    Undergo 18F-FES PET/CT
    Other Names:
    • 16 alpha-fluroestradiol-17 beta
    • F-18 FES
    • FES
    • Fluorine-18 16 alpha-fluoroestradiol
  • Procedure: Positron Emission Tomography
    Undergo 18F-FES PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
  • Procedure: Computed Tomography
    Undergo 18F-FES PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • CT
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Experimental: Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Interventions:
  • Radiation: F-18 16 Alpha-Fluoroestradiol
  • Procedure: Positron Emission Tomography
  • Procedure: Computed Tomography
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
 
NCT02374931
VICC SAR 1458
NCI-2015-00081 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VICC SAR 1458 ( Other Identifier: Vanderbilt-Ingram Cancer Center )
P30CA068485 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Katherine Hartley, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Katherine Hartley, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP