Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
Public ClinicalTrials.gov record NCT05068726. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Utility of Fluoroestradiol F18 PET/CT in Metastatic Breast Cancer Patients With ER-Positive and HER2-Negative Primary Lesions After Progression on First Line Hormonal Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna PET/CT scan. The treating physician will complete a standardized questionnaire to indicate the second-line therapeutic management plan before the scheduled Cerianna PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine physician, the treating physician will fill out a similar questionnaire to specify the final therapeutic decision. The proportion of patients with a change in therapeutic management plan based on Cerianna PET/CT results will be the primary endpoint. During the study follow-up period of 18 months, data on standard-of-care imaging, treatments/procedures received, and clinical outcomes will be collected. Patients will be asked to complete a health-related quality of life questionnaire at their screening, 6-month, and 18-month visit. Secondary endpoints include visual and quantitative heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18 months after Cerianna PET/CT, which will be assessed between patients with and without a change in therapeutic management plan. Maximum duration of follow-up for each patient: 20 months. First patient first visit to last patient last visit: estimated 36 months.
Study identification
- NCT ID
- NCT05068726
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 5, 2023 (Actual)
- Primary completion
- Jun 1, 2024 (Actual)
- Completion
- Jun 1, 2024 (Actual)
- Last update posted
- Jul 31, 2024
2023 – 2024
United States locations
- U.S. sites
- 24
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northern Arizona Healthcare | Flagstaff | Arizona | 86001 | — |
| TOI Clinical Research | Cerritos | California | 90703 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| PET/CT Imaging of San Jose | San Jose | California | 95128 | — |
| Providence Saint John's Health Center | Santa Monica | California | 90404 | — |
| Valley Breast Care | Van Nuys | California | 91405 | — |
| Tampa General Hospital Cancer Institute | Tampa | Florida | 33606 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| MD Clinics | Shreveport | Louisiana | 71104 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| The New York Presbyterian Hospital-Columbia University Medical Center | New York | New York | 10032 | — |
| WakeMed | Cary | North Carolina | 27610 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Kettering Health Cancer Center | Kettering | Ohio | 45429 | — |
| St. Luke's University Health Network | Allentown | Pennsylvania | 18102 | — |
| University of Pennsylvania / Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Baylor Research Institute d/b/a Baylor Scott & White Research Institute | Dallas | Texas | 75204 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05068726, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05068726 live on ClinicalTrials.gov.