Optimal Timing of BR55 CEUS of the Ovaries

NCT04248153 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-08-23

Study results available
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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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04248153 on ClinicalTrials.gov