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

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ClinicalTrials.gov Identifier: NCT02374931
Recruitment Status : Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Katherine Hartley, Vanderbilt-Ingram Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Deep Fibromatosis/Desmoid Tumor Familial Adenomatous Polyposis Drug: F-18 16 Alpha-Fluoroestradiol Procedure: Positron Emission Tomography Procedure: Computed Tomography Other: Laboratory Biomarker Analysis Early Phase 1

Detailed 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
Study Start Date : April 2015
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (18F-FES PET/CT)
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
 Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374931


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Katherine Hartley, MD Vanderbilt-Ingram Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial  This link exits the ClinicalTrials.gov site

Responsible Party: Katherine Hartley, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02374931     History of Changes
Other Study ID Numbers: 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 )
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Katherine Hartley, Vanderbilt-Ingram Cancer Center:
desmoid
FES-PET
aggressive fibromatosis

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Adenomatous Polyposis Coli
Fibromatosis, Aggressive
 Fibroma
Adenomatous Polyps
Adenoma
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs