Deep Fibromatosis/Desmoid TumorEarly Phase 1NCT02374931
18F-FES PET/CT in Imaging Patients With Desmoid Tumors
A Early Phase 1 study testing F-18 16 Alpha-Fluoroestradiol, Positron Emission Tomography and Computed Tomography in people with Deep Fibromatosis/Desmoid Tumor and Familial Adenomatous Polyposis, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Fibromatosis/Desmoid Tumor, Familial Adenomatous Polyposis
- What is being tested?
- F-18 16 Alpha-Fluoroestradiol, Positron Emission Tomography and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or nursing patients
- Patients who do not wish to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- F-18 16 Alpha-Fluoroestradiol, Positron Emission Tomography, Computed Tomography, Laboratory Biomarker Analysis
- Keywords
- desmoid, FES-PET, aggressive fibromatosis
- Medical subject headings
- Desmoid Tumors, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 16 Alpha-FluoroestradiolDrug
Also called 16 alpha-fluroestradiol-17 beta, F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiol
Undergo 18F-FES PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo 18F-FES PET/CT
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, CT
Undergo 18F-FES PET/CT
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-FES PET/CT) | Experimental | Patients undergo 18F-FES PET/CT imaging over 30 minutes. Receives: Drug: F-18 16 Alpha-Fluoroestradiol; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial visit, average within 24 hours of imaging
Secondary outcomes (1)
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.
Measured: Within 4 weeks of imaging done at initial visit, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2017
- Study completionDec 2017
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Fibromatosis/Desmoid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ashish Patel, Vanderbilt-Ingram Cancer Center
- Investigators
- Ashish Patel, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374931
- Sponsor's protocol ID
- VICC SAR 1458
- Other IDs
- NCI-2015-00081, VICC SAR 1458, P30CA068485
- Status last verified
- Sep 2019
- First submitted
- 16 Feb 2015
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of 18F-FES PET/CT Imaging of Desmoid Tumors
- ClinicalTrials.gov ID
- NCT02374931
- Acronym / sponsor ID
- VICC SAR 1458
- Keywords
- desmoid, FES-PET, aggressive fibromatosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-FES PET/CT) | Experimental | Drug: F-18 16 Alpha-Fluoroestradiol, Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Other: Laboratory Biomarker AnalysisPatients undergo 18F-FES PET/CT imaging over 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or nursing patients
- Patients who do not wish to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18 16 Alpha-FluoroestradiolAlso: 16 alpha-fluroestradiol-17 beta, F-18 FES, FES, Fluorine-18 16 alpha-fluoroestradiolUndergo 18F-FES PET/CT | Drug | Diagnostic (18F-FES PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo 18F-FES PET/CT | Procedure or surgery | Diagnostic (18F-FES PET/CT) |
| Computed TomographyAlso: CAT, CAT Scan, CTUndergo 18F-FES PET/CT | Procedure or surgery | Diagnostic (18F-FES PET/CT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (18F-FES PET/CT) |
Primary outcome
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.
1 secondary outcome
IHC staining intensity in tissue samples
Time frame: Within 4 weeks of imaging done at initial visit, day 1
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashish Patel, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing F-18 16 Alpha-Fluoroestradiol, Positron Emission Tomography and Computed Tomography in people with Deep Fibromatosis/Desmoid Tumor and Familial Adenomatous Polyposis, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value (SUV) measured as percent injected dose per cc (time frame: Initial visit, average within 24 hours of imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.