drugset / Trial / NCT04248153
Optimal Timing of BR55 CEUS of the Ovaries
RandomizedParallel-groupOpen-labelDiagnostic
Summary
This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.
Timeline
- Start
- 2019-10-14
- Primary completion
- 2020-02-19
- Completion
- 2021-07-31
Outcome
Outcome not reported
Stopped (Enrollment): “Sponsor decision; expiration of available study agent due to long recruitment timeline.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BR55 | Diagnostic / imaging agent | 0.03 ml | — |
| Subject | BR55 | Diagnostic / imaging agent | 0.05 ml | — |