NCT04692103Active, not recruitingPhase 2
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy
Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- First submitted
- 30 Dec 2020
- Start date
- 10 Jul 2021
- Primary completion date
- 1 Oct 2021
- Lead sponsor
- University of Washington
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04692103
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 2
- From 10 Jul 2021 to the primary completion date, 1 Oct 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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, DES or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan.
Lab values
- Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL)
Other
- 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.
- Adult patients who require monitored anesthesia for PET scanning.
Who the study is looking for
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.