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NCT02455453 · ClinicalTrials.gov registry record · Phase 2
Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT02455453 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 47 participants.
The verdict
NCT02455453, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the uptake of a radioactive tracer 21-18F-fluoro-16α,17α-\[(R)-(1'-α-furylmethylidene)dioxy\]-19-norpregn-4-ene-3,20-dione (FFNP) uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before and after administration of estradiol for one day (estrogen challenge) to determine if the change in uptake is a predictor of response to endocrine therapy (ET) in patients with hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat metastatic breast cancer. The investigators propose to study patients with biopsy-proven newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as standard of care therapy. Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one immediately following the one day estradiol challenge before the start of standard of care ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally (three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.
Interventions
- DRUG 18F-FDG
- DRUG Estradiol
- DRUG 18F-FFNP
- DEVICE CTI/Siemens Biograph 40 PET/CT Scanner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-04-28 |
| Est. Completion | 2019-01-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02455453
The ClinicalTrials.gov registry entry for NCT02455453 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 18F-FDG is the first listed.
NCT02455453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02455453 about?
NCT02455453 is a clinical study titled "Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography". The purpose of this study is to evaluate the uptake of a radioactive tracer 21-18F-fluoro-16α,17α-\[(R)-(1'-α-furylmethylidene)dioxy\]-19-norpregn-4-ene-3,20-dione (FFNP) uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before and after administration of estradiol ...
What is the current status of trial NCT02455453?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2015-04-28. Estimated completion is 2019-01-03.
What interventions are being tested in trial NCT02455453?
The interventions under investigation include: 18F-FDG (DRUG), Estradiol (DRUG), 18F-FFNP (DRUG), CTI/Siemens Biograph 40 PET/CT Scanner (DEVICE).
Who is sponsoring clinical trial NCT02455453?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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