Clinical trial · Interventional
Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET
Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET and Predictive Measure for Endocrine Therapy Response in Patients With Newly Diagnosed Metastatic Breast Cancer
NCT03065712CI-TRIAL-00045048withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Competing clinical trial
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| F-18 Fluoroestradiol | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FES PET/CT
- description
- 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
- interventionNames
- Drug: F-18 Fluoroestradiol
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Repeatablility coefficient
- timeFrame
- Repeatable FES PET/CT scans are performed within 10 days
- description
- Maximum standardized uptake value repeatability coefficient
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: . Patients not meeting the inclusion criteria.
References
Publications (8)
- BACKGROUNDMintun 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 3262228
- BACKGROUNDMortimer 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 11387350
- BACKGROUNDMortimer 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 9816253
- BACKGROUNDLinden 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 16682724
- BACKGROUNDKurland 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 21903739
- BACKGROUNDDehdashti 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.