Clinical trial · Interventional
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
NCT04692103CI-TRIAL-00116486active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| Primary or Recurrent Breast Carcinoma | — | UNRESOLVED | — |
| Stage IV Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| F-18 16 Alpha-Fluoroestradiol | Drug | — | UNRESOLVED |
| Fludeoxyglucose F-18 | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (F-18 FES PET/CT)
- description
- 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.
- interventionNames
- Drug: F-18 16 Alpha-Fluoroestradiol
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
- Drug: Fludeoxyglucose F-18
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax
- timeFrame
- From time of first F-18 FES-PET/CT scan to time of second F-18 FES-PET/CT scan (approximately 1-12 weeks)
- description
- FES uptake will be quantified using lean body mass adjusted SUV (SUL). Percentage change in FES average SULmax between baseline and a second FES scan will be calculated for up to 3 lesions per patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * Ability to understand and the willingness to sign a written informed consent document. 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, DES or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan. * Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL) * Adult patients who require monitored anesthesia for PET scanning.
References
Publications (0)
Data not yet available
No reference posted for this study.