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F-18 FES PET in Measuring Hormone Expression in Patients With Recurrent or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy

Complete title: Serial [F-18] fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-Targeted Therapy

Research Study Number       7184
    
Principal Investigator       Hannah Linden, MD
    
Phase       NA

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Research Study Description

This clinical trial studies F-18 16 alpha-fluoroestradiol (F-18 FES) positron emission tomography (PET) in measuring hormone expression in patients with recurrent or metastatic breast cancer undergoing endocrine-targeted therapy. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- An inability to lie still for the tests

- 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

Other exclusion criteria may apply.



Research Study Number       7184
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Breast Cancer; Solid Tumors

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