18F-FES PET/CT in Imaging Patients With Desmoid Tumors
Primary Purpose
Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
F-18 16 Alpha-Fluoroestradiol
Positron Emission Tomography
Computed Tomography
Laboratory Biomarker Analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Deep Fibromatosis/Desmoid Tumor focused on measuring desmoid, FES-PET, aggressive fibromatosis
Eligibility 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
Sites / Locations
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (18F-FES PET/CT)
Arm Description
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02374931
First Posted
February 16, 2015
Last Updated
September 30, 2019
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02374931
Brief Title
18F-FES PET/CT in Imaging Patients With Desmoid Tumors
Official Title
Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis
Keywords
desmoid, FES-PET, aggressive fibromatosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (18F-FES PET/CT)
Arm Type
Experimental
Arm Description
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
F-18 16 Alpha-Fluoroestradiol
Other Intervention Name(s)
16 alpha-fluroestradiol-17 beta, F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol
Intervention Description
Undergo 18F-FES PET/CT
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Intervention Description
Undergo 18F-FES PET/CT
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, CT
Intervention Description
Undergo 18F-FES PET/CT
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Standard uptake value (SUV) measured as percent injected dose per cc
Description
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.
Time Frame
Initial visit, average within 24 hours of imaging
Secondary Outcome Measure Information:
Title
IHC staining intensity in tissue samples
Description
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.
Time Frame
Within 4 weeks of imaging done at initial visit, day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish Patel, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Links:
URL
http://vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
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18F-FES PET/CT in Imaging Patients With Desmoid Tumors
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