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18F-FES PET/CT in Imaging Patients With Desmoid Tumors
Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
3 other identifiers
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Apr 2015
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 3, 2019
September 1, 2019
2.3 years
February 16, 2015
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Initial visit, average within 24 hours of imaging
Secondary Outcomes (1)
IHC staining intensity in tissue samples
Within 4 weeks of imaging done at initial visit, day 1
Study Arms (1)
Diagnostic (18F-FES PET/CT)
EXPERIMENTALPatients undergo 18F-FES PET/CT imaging over 30 minutes.
Interventions
Undergo 18F-FES PET/CT
Undergo 18F-FES PET/CT
Undergo 18F-FES PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or nursing patients
- Patients who do not wish to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashish Patel, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2015
First Posted
March 2, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
October 3, 2019
Record last verified: 2019-09