F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy
NCT ID: NCT02149173
Last Updated: 2021-06-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
29 participants
INTERVENTIONAL
2010-09-15
2021-01-13
Brief Summary
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Detailed Description
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I. Measure the effect of endocrine targeted therapy on estrogen receptor (ER) expression and estradiol binding to the receptor using serial FES PET and fludeoxyglucose F-18 (FDG) PET.
SECONDARY OBJECTIVES:
I. Document the safety profile of FES PET in patients with breast cancer.
II. Examine associations between FES PET results and serial measurements of hormone or other levels in peripheral blood, as related to efficacy of endocrine-targeted therapy. Correlate FES PET uptake measures with histopathological assays and tumor microenvironment studies on biopsy specimens, if relevant to specific treatment regimen.
OUTLINE:
Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
After completion of study, patients are followed up for up to 20 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (F-18 FES PET/CT)
Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.
Computed Tomography
Undergo F-18 FES PET/CT
Computed Tomography
Undergo FDG PET/CT
F-18 16 Alpha-Fluoroestradiol
Undergo F-18 FES PET/CT
Fludeoxyglucose F-18
Undergo FDG PET/CT
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo F-18 FES PET/CT
Positron Emission Tomography
Undergo FDG PET/CT
Interventions
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Computed Tomography
Undergo F-18 FES PET/CT
Computed Tomography
Undergo FDG PET/CT
F-18 16 Alpha-Fluoroestradiol
Undergo F-18 FES PET/CT
Fludeoxyglucose F-18
Undergo FDG PET/CT
Laboratory Biomarker Analysis
Correlative studies
Positron Emission Tomography
Undergo F-18 FES PET/CT
Positron Emission Tomography
Undergo FDG PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Breast cancer from ER+ primary that is seen on other imaging tests; tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease
* At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging
* Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES
* Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
* Patients must be willing to undergo serial imaging procedures
* Patients must agree to allow access to clinical records regarding response to treatment and long term follow up
Exclusion Criteria
* Individuals weighing more than 300 lb; (this is the weight limit of the scanner table)
* Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded
* Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
* Use of tamoxifen, Faslodex, diethylstilbestrol (DES) or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan
* Unwillingness or inability to give informed consent
* Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL)
* Adult patients who require monitored anesthesia for PET scanning
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Hannah Linden
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2013-02342
Identifier Type: REGISTRY
Identifier Source: secondary_id
7184
Identifier Type: OTHER
Identifier Source: secondary_id
RG1711032
Identifier Type: OTHER
Identifier Source: secondary_id
7184
Identifier Type: -
Identifier Source: org_study_id
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