Study Stopped
Competing clinical trial
Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2017
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2021
CompletedMay 12, 2020
August 1, 2019
3 years
February 20, 2017
May 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Repeatablility coefficient
Maximum standardized uptake value repeatability coefficient
Repeatable FES PET/CT scans are performed within 10 days
Secondary Outcomes (1)
Negative Predictive Value
6 months after treatment completion
Study Arms (1)
FES PET/CT
EXPERIMENTALThis 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
Interventions
F-18 Fluoroestradiol will be administered for PET/CT scan.
Undergo PET/CT
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clements University Hospital
Dallas, Texas, 75390, United States
Related Publications (8)
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.
PMID: 3262228BACKGROUNDMortimer 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.
PMID: 11387350BACKGROUNDMortimer 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.
PMID: 9816253BACKGROUNDLinden 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.
PMID: 16682724BACKGROUNDKurland 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.
PMID: 21903739BACKGROUNDDehdashti 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.
PMID: 18327670BACKGROUNDLinden 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.
PMID: 21750198BACKGROUNDPeterson 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.
PMID: 24170452BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rathan Subramaniam, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 28, 2017
Study Start
February 22, 2017
Primary Completion
February 22, 2020
Study Completion
February 20, 2021
Last Updated
May 12, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share