Breast CancerPhase 2NCT03065712
Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET
A Phase 2 study testing F-18 Fluoroestradiol, Computed Tomography and Positron Emission Tomography in people with Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study will formally address the hypothesis that FES-PET/CT measurement of ER expression predicts clinical benefit of first-line endocrine therapy in newly diagnosed ER+ metastatic breast cancer patients and establishes the repeatability of FES PET/CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- F-18 Fluoroestradiol, Computed Tomography and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 20 Feb 2021
- Phase
- Phase 2
- 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 must be over 18 years old and capable and willing to provide informed consent.
- Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to PET/CT imaging per institution's standard of care;
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria;
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Medically stable as judged by patient's physician.
Show all 17Show fewer
- Life expectancy must be estimated at > 6 months.
- Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FES are NOT eligible.
- Patients with liver failure are NOT eligible.
- Patient must NOT be breast-feeding.
- Histologically confirmed ER+ breast cancer either from a metastatic biopsy or from a primary breast tumor with imaging evidence of metastatic disease. The pathology report and either (1) tumor tissue (blocks or unstained slides) or (2) a photomicrograph of the ER IHC slide from at least one site of metastatic disease
- No prior endocrine therapy for metastatic disease is allowed (i.e. must be first-line endocrine therapy for metastatic disease). However, a history of adjuvant endocrine therapy is allowed, as long as the date of diagnosis of metastatic disease is > 2 years following initiation of adjuvant endocrine therapy. Patients who develop metastatic disease while still receiving adjuvant endocrine therapy must have a change in the type of endocrine agent used for subsequent metastatic disease treatment. Patients on blocking adjuvant therapy (with a blocking agent such as toremifene or tamoxifen) must be off the agents for a minimum of 60 days to allow for adequate uptake of FES
- Patients with human epidermal growth factor-2 positive (HER2+) metastatic tumors are NOT eligible
- Postmenopausal women, men, or premenopausal women for whom endocrine therapy (tamoxifen, aromatase inhibitor (AI) with or without ovarian suppression or fulvestrant), with or without a CDK4/6 inhibitor is planned after FES-PET/CT is completed
- Disease may be measurable (by RECIST 1.1 criteria) or non-measurable but must be present in at least one non-liver site, 1.5 cm or greater and visualized on PET/CT with [18F]-fluorodeoxyglucose (FDG). Patients with effusion only disease or disease only in the liver are not eligible for the study
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan.
Who cannot join
- . Patients not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET and Predictive Measure for Endocrine Therapy Response in Patients With Newly Diagnosed Metastatic Breast Cancer
This study will formally address the hypothesis that FES-PET/CT measurement of ER expression predicts clinical benefit of first-line endocrine therapy in newly diagnosed ER+ metastatic breast cancer patients and establishes the repeatability of FES PET/CT.
Read the detailed description
The experimental FES-PET/CT is required to be completed 0 to 30 days prior to initiation of first-line endocrine therapy for metastatic ER+ breast cancer. Labs and correlative radiology, as directed per clinical care, are required within 60 days prior to FES-PET/CT; and FDG-PET/CT is required within 60 days before the FES-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
Visit 1: Patients will have at least one visit with investigator (or investigator designee) prior to the study to review clinical history and prior treatment of primary breast cancer, and to explain the study. Correlative radiology studies including CT, MRI, or bone scan as per institutional routine clinical care, and any clinically-directed laboratory tests performed as part of metastatic staging must be performed within 60 days of the FES-PET/CT.
Visit 2: The patient will have a clinically-directed FDG-PET/CT as part of metastatic staging. The FDG-PET/CT will usually be obtained within 60 days prior to the FES-PET/CT. It may be done up to 30 days before the FES-PET/CT if there has been no endocrine therapy for metastatic disease started before the FES-PET/CT. The FDG-PET/CT and FES-PET/CT cannot be performed on the same day due to the half-life of F-18. The FDG-PET/CT may be done as a research scan, if the patient is unable to obtain a clinically-directed FDG-PET/CT as part of their clinical care or within 60 days of FES PET/CT. The research FDG-PET/CT, in this instance, will be identical in procedure to the institution's clinical FDG-PET/CT. The blood glucose level will be < 200 mg/dl, before FDG injection, which is institutional standard clinical protocol. The following additional patient data will be obtained: histological diagnosis of primary and/or metastatic disease, date of diagnosis of primary and metastatic disease, gender, height, weight (for BMI), ECOG score, and prior adjuvant and metastatic treatment regimens used.
Visit 3 - Day of FES PET/CT: The patient will have an intravenous line placed typically in the hand or arm opposite to the known primary breast cancer, FES will be given by 2 minute infusion, and the dose administered will be approximately 6mCi +/- 20%. After approximately 60+/- 10 minutes of uptake time, the patient will be positioned supine in the PET/CT scanner for standard whole body PET/CT scan from the skull base to mid-thigh. This scan will take approximately 20-30 min. If there are any breast lesions, a higher resolution PEM study of the breast/s may be obtained which make take approximately an additional 30-60 min.
A blood sample to be obtained, just before the FES injection, and submitted for hormonal analysis (estradiol and sex hormone binding globulin).
Visit 4-Day of Reproducibility FES-PET/CT: The test re-test FES-PET/CT will need to be performed at least 24 hours after the first FES-PET/CT and no later than 10 days following the initial FES study, and it can be done at any time after the FDG-PET/CT. The second FES-PET/CT study must be performed on the same scanner as the first FES-PET/CT and the imaging protocol described in Visit 3 should be closely followed. If there are any breast lesions, a higher resolution PEM study may be obtained which make take approximately an additional 30 min.
Visit 5-Week 1 to 4 after first FES-PET/CT: Patients will start endocrine therapy in the period from 0 to 30 days post FES-PET/CT, as per clinical standard.
- Conditions
- Breast Cancer
- Being tested
- F-18 Fluoroestradiol, Computed Tomography, Positron Emission Tomography, Laboratory Biomarker Analysis
- Keywords
- Breast Cancer, PET/CT, FES, 18F Fluoroestradiol, Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FluoroestradiolDrug
Also called FES PET/CT, F-18 Fluoroestradiol PET/CT
F-18 Fluoroestradiol will be administered for PET/CT scan.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, CT Scan
Undergo PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan
Undergo PET/CT
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| FES PET/CT | Experimental | This is a single arm study that involves FES PET/CT.
Procedure: Computed Tomography
* Drug: [F-18] fluoroestradiol: [F-18]FES
* Other: Laboratory Biomarker Analysis
* Procedure: Positron Emission Tomography Receives: Drug: F-18 Fluoroestradiol; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatablility coefficient
Maximum standardized uptake value repeatability coefficient
Measured: Repeatable FES PET/CT scans are performed within 10 days
Secondary outcomes (1)
Negative Predictive Value
Negative Predictive Value of baseline FES PET/CT
Measured: 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start22 Feb 2017
- Primary completion22 Feb 2020 (estimated)
- Study completion20 Feb 2021 (estimated)
Why it stopped: Competing clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rathan Subramaniam, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065712
- Sponsor's protocol ID
- STU 032016-021
- Status last verified
- Aug 2019
- First submitted
- 20 Feb 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mintun MA, Welch MJ, Siegel BA, Mathias CJ, Brodack JW, McGuire AH, Katzenellenbogen JA. Breast cancer: PET imaging of estrogen receptors. Radiology. 1988 Oct;169(1):45-8. doi: 10.1148/radiology.169.1.3262228.
PubMed 3262228Mortimer JE, Dehdashti F, Siegel BA, Trinkaus K, Katzenellenbogen JA, Welch MJ. Metabolic flare: indicator of hormone responsiveness in advanced breast cancer. J Clin Oncol. 2001 Jun 1;19(11):2797-803. doi: 10.1200/JCO.2001.19.11.2797.
PubMed 11387350Mortimer JE, Dehdashti F, Siegel BA, Katzenellenbogen JA, Fracasso P, Welch MJ. Positron emission tomography with 2-[18F]Fluoro-2-deoxy-D-glucose and 16alpha-[18F]fluoro-17beta-estradiol in breast cancer: correlation with estrogen receptor status and response to systemic therapy. Clin Cancer Res. 1996 Jun;2(6):933-9.
PubMed 9816253Linden HM, Stekhova SA, Link JM, Gralow JR, Livingston RB, Ellis GK, Petra PH, Peterson LM, Schubert EK, Dunnwald LK, Krohn KA, Mankoff DA. Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. J Clin Oncol. 2006 Jun 20;24(18):2793-9. doi: 10.1200/JCO.2005.04.3810. Epub 2006 May 8.
PubMed 16682724Kurland BF, Peterson LM, Lee JH, Linden HM, Schubert EK, Dunnwald LK, Link JM, Krohn KA, Mankoff DA. Between-patient and within-patient (site-to-site) variability in estrogen receptor binding, measured in vivo by 18F-fluoroestradiol PET. J Nucl Med. 2011 Oct;52(10):1541-9. doi: 10.2967/jnumed.111.091439. Epub 2011 Sep 8.
PubMed 21903739Dehdashti F, Mortimer JE, Trinkaus K, Naughton MJ, Ellis M, Katzenellenbogen JA, Welch MJ, Siegel BA. PET-based estradiol challenge as a predictive biomarker of response to endocrine therapy in women with estrogen-receptor-positive breast cancer. Breast Cancer Res Treat. 2009 Feb;113(3):509-17. doi: 10.1007/s10549-008-9953-0. Epub 2008 Mar 9.
PubMed 18327670Linden HM, Kurland BF, Peterson LM, Schubert EK, Gralow JR, Specht JM, Ellis GK, Lawton TJ, Livingston RB, Petra PH, Link JM, Krohn KA, Mankoff DA. Fluoroestradiol positron emission tomography reveals differences in pharmacodynamics of aromatase inhibitors, tamoxifen, and fulvestrant in patients with metastatic breast cancer. Clin Cancer Res. 2011 Jul 15;17(14):4799-805. doi: 10.1158/1078-0432.CCR-10-3321. Epub 2011 Jul 12.
PubMed 21750198Peterson LM, Kurland BF, Schubert EK, Link JM, Gadi VK, Specht JM, Eary JF, Porter P, Shankar LK, Mankoff DA, Linden HM. A phase 2 study of 16alpha-[18F]-fluoro-17beta-estradiol positron emission tomography (FES-PET) as a marker of hormone sensitivity in metastatic breast cancer (MBC). Mol Imaging Biol. 2014 Jun;16(3):431-40. doi: 10.1007/s11307-013-0699-7. Epub 2013 Oct 30.
PubMed 24170452
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET and Predictive Measure for Endocrine Therapy Response in Patients With Newly Diagnosed Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03065712
- Acronym / sponsor ID
- STU 032016-021
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, PET/CT, FES, 18F Fluoroestradiol, Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Competing clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 22 Feb 2020 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 28 Feb 2017 (actual)
- 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 study will formally address the hypothesis that FES-PET/CT measurement of ER expression predicts clinical benefit of first-line endocrine therapy in newly diagnosed ER+ metastatic breast cancer patients and establishes the repeatability of FES PET/CT.
Detailed description
The experimental FES-PET/CT is required to be completed 0 to 30 days prior to initiation of first-line endocrine therapy for metastatic ER+ breast cancer. Labs and correlative radiology, as directed per clinical care, are required within 60 days prior to FES-PET/CT; and FDG-PET/CT is required within 60 days before the FES-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
Visit 1: Patients will have at least one visit with investigator (or investigator designee) prior to the study to review clinical history and prior treatment of primary breast cancer, and to explain the study. Correlative radiology studies including CT, MRI, or bone scan as per institutional routine clinical care, and any clinically-directed laboratory tests performed as part of metastatic staging must be performed within 60 days of the FES-PET/CT.
Visit 2: The patient will have a clinically-directed FDG-PET/CT as part of metastatic staging. The FDG-PET/CT will usually be obtained within 60 days prior to the FES-PET/CT. It may be done up to 30 days before the FES-PET/CT if there has been no endocrine therapy for metastatic disease started before the FES-PET/CT. The FDG-PET/CT and FES-PET/CT cannot be performed on the same day due to the half-life of F-18. The FDG-PET/CT may be done as a research scan, if the patient is unable to obtain a clinically-directed FDG-PET/CT as part of their clinical care or within 60 days of FES PET/CT. The research FDG-PET/CT, in this instance, will be identical in procedure to the institution's clinical FDG-PET/CT. The blood glucose level will be < 200 mg/dl, before FDG injection, which is institutional standard clinical protocol. The following additional patient data will be obtained: histological diagnosis of primary and/or metastatic disease, date of diagnosis of primary and metastatic disease, gender, height, weight (for BMI), ECOG score, and prior adjuvant and metastatic treatment regimens used.
Visit 3 - Day of FES PET/CT: The patient will have an intravenous line placed typically in the hand or arm opposite to the known primary breast cancer, FES will be given by 2 minute infusion, and the dose administered will be approximately 6mCi +/- 20%. After approximately 60+/- 10 minutes of uptake time, the patient will be positioned supine in the PET/CT scanner for standard whole body PET/CT scan from the skull base to mid-thigh. This scan will take approximately 20-30 min. If there are any breast lesions, a higher resolution PEM study of the breast/s may be obtained which make take approximately an additional 30-60 min.
A blood sample to be obtained, just before the FES injection, and submitted for hormonal analysis (estradiol and sex hormone binding globulin).
Visit 4-Day of Reproducibility FES-PET/CT: The test re-test FES-PET/CT will need to be performed at least 24 hours after the first FES-PET/CT and no later than 10 days following the initial FES study, and it can be done at any time after the FDG-PET/CT. The second FES-PET/CT study must be performed on the same scanner as the first FES-PET/CT and the imaging protocol described in Visit 3 should be closely followed. If there are any breast lesions, a higher resolution PEM study may be obtained which make take approximately an additional 30 min.
Visit 5-Week 1 to 4 after first FES-PET/CT: Patients will start endocrine therapy in the period from 0 to 30 days post FES-PET/CT, as per clinical standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES PET/CT | Experimental | Drug: F-18 Fluoroestradiol, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Laboratory Biomarker AnalysisThis is a single arm study that involves FES PET/CT. Procedure: Computed Tomography * Drug: [F-18] fluoroestradiol: [F-18]FES * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must be over 18 years old and capable and willing to provide informed consent.
- Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to PET/CT imaging per institution's standard of care;
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria;
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Key exclusion criteria (1 listed)
- . Patients not meeting the inclusion criteria.
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 FluoroestradiolAlso: FES PET/CT, F-18 Fluoroestradiol PET/CTF-18 Fluoroestradiol will be administered for PET/CT scan. | Drug | FES PET/CT |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, CT ScanUndergo PET/CT | Procedure or surgery | FES PET/CT |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scanUndergo PET/CT | Procedure or surgery | FES PET/CT |
| Laboratory Biomarker AnalysisCorrelative studies | Other | FES PET/CT |
Primary outcome
Repeatablility coefficient
Time frame: Repeatable FES PET/CT scans are performed within 10 days
Maximum standardized uptake value repeatability coefficient
1 secondary outcome
Negative Predictive Value
Time frame: 6 months after treatment completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 3262228Mintun MA, Welch MJ, Siegel BA, Mathias CJ, Brodack JW, McGuire AH, Katzenellenbogen JA. Breast cancer: PET imaging of estrogen receptors. Radiology. 1988 Oct;169(1):45-8. doi: 10.1148/radiology.169.1.3262228.
- Background: PubMed 11387350Mortimer JE, Dehdashti F, Siegel BA, Trinkaus K, Katzenellenbogen JA, Welch MJ. Metabolic flare: indicator of hormone responsiveness in advanced breast cancer. J Clin Oncol. 2001 Jun 1;19(11):2797-803. doi: 10.1200/JCO.2001.19.11.2797.
- Background: PubMed 9816253Mortimer JE, Dehdashti F, Siegel BA, Katzenellenbogen JA, Fracasso P, Welch MJ. Positron emission tomography with 2-[18F]Fluoro-2-deoxy-D-glucose and 16alpha-[18F]fluoro-17beta-estradiol in breast cancer: correlation with estrogen receptor status and response to systemic therapy. Clin Cancer Res. 1996 Jun;2(6):933-9.
- Background: PubMed 16682724Linden HM, Stekhova SA, Link JM, Gralow JR, Livingston RB, Ellis GK, Petra PH, Peterson LM, Schubert EK, Dunnwald LK, Krohn KA, Mankoff DA. Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. J Clin Oncol. 2006 Jun 20;24(18):2793-9. doi: 10.1200/JCO.2005.04.3810. Epub 2006 May 8.
- Background: PubMed 21903739Kurland BF, Peterson LM, Lee JH, Linden HM, Schubert EK, Dunnwald LK, Link JM, Krohn KA, Mankoff DA. Between-patient and within-patient (site-to-site) variability in estrogen receptor binding, measured in vivo by 18F-fluoroestradiol PET. J Nucl Med. 2011 Oct;52(10):1541-9. doi: 10.2967/jnumed.111.091439. Epub 2011 Sep 8.
- Background: PubMed 18327670Dehdashti F, Mortimer JE, Trinkaus K, Naughton MJ, Ellis M, Katzenellenbogen JA, Welch MJ, Siegel BA. PET-based estradiol challenge as a predictive biomarker of response to endocrine therapy in women with estrogen-receptor-positive breast cancer. Breast Cancer Res Treat. 2009 Feb;113(3):509-17. doi: 10.1007/s10549-008-9953-0. Epub 2008 Mar 9.
- Background: PubMed 21750198Linden HM, Kurland BF, Peterson LM, Schubert EK, Gralow JR, Specht JM, Ellis GK, Lawton TJ, Livingston RB, Petra PH, Link JM, Krohn KA, Mankoff DA. Fluoroestradiol positron emission tomography reveals differences in pharmacodynamics of aromatase inhibitors, tamoxifen, and fulvestrant in patients with metastatic breast cancer. Clin Cancer Res. 2011 Jul 15;17(14):4799-805. doi: 10.1158/1078-0432.CCR-10-3321. Epub 2011 Jul 12.
- Background: PubMed 24170452Peterson LM, Kurland BF, Schubert EK, Link JM, Gadi VK, Specht JM, Eary JF, Porter P, Shankar LK, Mankoff DA, Linden HM. A phase 2 study of 16alpha-[18F]-fluoro-17beta-estradiol positron emission tomography (FES-PET) as a marker of hormone sensitivity in metastatic breast cancer (MBC). Mol Imaging Biol. 2014 Jun;16(3):431-40. doi: 10.1007/s11307-013-0699-7. Epub 2013 Oct 30.
- Individual participant dataSharing planned: No
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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.
Rathan Subramaniam, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-18 Fluoroestradiol, Computed Tomography and Positron Emission Tomography in people with Breast Cancer, run by University of Texas Southwestern Medical 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 17 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 May 2020. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Repeatablility coefficient (time frame: Repeatable FES PET/CT scans are performed within 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065712, which also lists 8 linked publications.
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 12 May 2020.