Trials / Active Not Recruiting
Active Not RecruitingNCT04692103
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OUTLINE: 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. After completion of study, patients are followed up for up to 20 years.
Conditions
- Estrogen Receptor Positive
- Primary or Recurrent Breast Carcinoma
- Stage IV Breast Cancer AJCC v6 and v7
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | F-18 16 Alpha-Fluoroestradiol | Undergo F-18 FES PET/CT |
| PROCEDURE | Positron Emission Tomography | Undergo F-18 FES PET/CT |
| PROCEDURE | Computed Tomography | Undergo F-18 FES PET/CT |
| DRUG | Fludeoxyglucose F-18 | Undergo FDG PET/CT |
| PROCEDURE | Positron Emission Tomography | Undergo FDG PET/CT |
| PROCEDURE | Computed Tomography | Undergo FDG PET/CT |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2021-07-10
- Primary completion
- 2021-10-01
- Completion
- 2041-04-30
- First posted
- 2020-12-31
- Last updated
- 2026-01-22
- Results posted
- 2023-02-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04692103. Inclusion in this directory is not an endorsement.