Overview

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

Status:
Terminated
Trial end date:
2021-01-13
Target enrollment:
0
Participant gender:
All
Summary
This clinical trial studies use of F-18 16 alpha-fluoroestradiol ([F-18] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborator:
National Cancer Institute (NCI)
Treatments:
Deoxyglucose
Fluorides
Fluorodeoxyglucose F18
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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