Optimal Timing of BR55 CEUS of the Ovaries
NCT04248153 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2024-08-23
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.
Conditions
Interventions
- DRUG
-
BR55
BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
Bracco Diagnostics, Inc
lead INDUSTRY
Principal Investigators
-
Luigia Storto, MD · Bracco Diagnostics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-14
- Primary Completion
- 2020-02-19
- Completion
- 2021-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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