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NCT05068726 · ClinicalTrials.gov registry record
Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
A clinical trial, sponsored by GE Healthcare.
- Terminated
- Registry status
- 51
- Enrollment target
NCT05068726: Clinical Trial study, sponsored by GE Healthcare.
NCT05068726 is a clinical trial that was terminated before completion, run by GE Healthcare. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05068726 was terminated before completion, sponsored by GE Healthcare.
- TERMINATED
- Registry status
- 51 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The percentage of subjects with changes in the therapeutic management plan after Cerianna PET/CT with 95% confidence interval will be estimated by comparison of the initial management plan vs. the post-Cerianna PET/CT management plan evaluated within 3 weeks after Cerianna PET/CT.
Interventions
- DRUG 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2024-06-01 |
Why NCT05068726 stopped before completion
NCT05068726 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which 18F Fluoroestradiol Radiopharmaceutical with PET/CT is the first listed.
NCT05068726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05068726 about?
NCT05068726 is a clinical study titled "Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients". 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 horm...
What is the current status of trial NCT05068726?
This trial is currently terminated. The enrollment target is 51 participants. The study started on 2023-01-05. Estimated completion is 2024-06-01.
What interventions are being tested in trial NCT05068726?
The interventions under investigation include: 18F Fluoroestradiol Radiopharmaceutical with PET/CT (DRUG).
Who is sponsoring clinical trial NCT05068726?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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