F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer

NCT00602043 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-19

Study results available
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Summary

This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women with hormone receptor-positive metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how well patients will respond to hormone therapy and may help plan the best treatment.

Conditions

  • Estrogen Receptor-positive Breast Cancer
  • Progesterone Receptor-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Interventions

RADIATION

F-18 16 alpha-fluoroestradiol

Undergo \[\^18F\] FES PET

RADIATION

fludeoxyglucose F 18

Undergo standard clinical FDG PET/CT

PROCEDURE

positron emission tomography

Undergo \[\^18F\] FES PET

PROCEDURE

positron emission tomography

Undergo standard clinical FDG PET/CT

PROCEDURE

computed tomography

Undergo standard clinical FDG PET/CT

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Janet F Eary, MD · Department of Radiology, University of Alabama, Birmingham, AL

  • David A Mankoff, MD, PhD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-08-31
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00602043 on ClinicalTrials.gov