An Early Phase 1 interventional study of F-18 16 Alpha-Fluoroestradiol and Positron Emission Tomography in Deep Fibromatosis/Desmoid Tumor and Familial Adenomatous Polyposis, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by Vanderbilt-Ingram Cancer Center · Early Phase 1, Interventional, and Diagnostic
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Among 33 studies in Desmoid Tumors with a site in United States — 6 open to participants now, 9 under way, 1 of them phase 3. Desmoid Tumors · United States.
Among the 33 studies in Desmoid Tumors with a site in United States, this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 4 that started in 2015, is one of 6 in phase 1, and was the 15th registered.
71 studies on the registry are indexed under Desmoid Tumors; 21 are open to participants now.
Browse Desmoid Tumors studies →6 of the 33 studies in Desmoid Tumors with a site in United States are open now. Recruiting first, the newest first:
Nam Bui · Sites in United States
Ages 18+
Parabilis Medicines, Inc. · Sites in United States, Australia
Ages 18+
Children's Oncology Group · Sites in United States
Ages 12 mo–30 yrs
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Children's Oncology Group · Sites in United States, Australia, Canada and 3 more countries
Ages up to 25
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Desmoid Tumors studies recruiting now, 13 (76%) set no upper age limit and 4 (24%) stop at 75 or younger; 6 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 13 · Phase 3 4
First in 1991; this study’s year is marked. 4 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 44 across 47 interventional studies indexed under Desmoid Tumors.
Median enrollment 43 across the 24 interventional studies, 150 across the 7 observational. Of the 20 that completed or were terminated, 9 (45%) have results posted.
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6 of 33 have an industry lead sponsor. The 10 most frequent:
Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Vanderbilt-Ingram Cancer Center has 1 study filed under Desmoid Tumors — fewer than ten, so there is no comparison to draw.
2 of the studies in Desmoid Tumors with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04281381Memorial Sloan Kettering Cancer CenterObserving People With Desmoid-Type Fibromatosis | 2027-02-19 |
| NCT05919264Parabilis Medicines, Inc.FOG-001 in Locally Advanced or Metastatic Solid Tumors | 2027-04-01 |
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Among the 33 studies in Desmoid Tumors with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo 18F-FES PET/CT imaging over 30 minutes.
Drug: F-18 16 Alpha-Fluoroestradiol · Procedure: Positron Emission Tomography · Procedure: Computed Tomography · Other: Laboratory Biomarker Analysis
Undergo 18F-FES PET/CT
Also known as: 16 alpha-fluroestradiol-17 beta, F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol
Undergo 18F-FES PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo 18F-FES PET/CT
Also known as: CAT, CAT Scan, CT
Correlative studies
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.
Time frame: Initial visit, average within 24 hours of imaging
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.
Time frame: Within 4 weeks of imaging done at initial visit, day 1
The record gives a start of Apr 2015, a primary completion of Jul 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluoroestradiol f-18
Vanderbilt-Ingram Cancer Center →