Optimal Timing of BR55 CEUS of the Ovaries

NCT ID: NCT04248153

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2021-07-31

Brief 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

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group A

BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.

Group Type: EXPERIMENTAL

BR55

Intervention Type: DRUG

BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg

Group B

BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.

Group Type: EXPERIMENTAL

BR55

Intervention Type: DRUG

BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg

Interventions

BR55

BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Is a female subject of at least 18 years of age;
• Is premenopausal;
• Is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian cancer not earlier than 24 hours and not later than 5 days following the second BR55 CEUS examination;
• Provides written Informed Consent and is willing to comply with protocol requirements.

• Is a pregnant or lactating female. Exclude the possibility of pregnancy:

• by testing on site at the institution (serum βHCG) within 24 hours prior to the start of investigational product administration,
• by surgical history (e.g., tubal ligation or hysterectomy),
• Has undergone prior systemic therapy for ovarian cancer;
• Has history of concurrent malignancy;
• Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure;
• Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;
• Has severe pulmonary hypertension (pulmonary artery pressure >90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome;
• Has open and/or non-healing wounds in the chest, abdomen and pelvis;
• Has other systemic vascular abnormalities associated with neovascularization that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55;
• Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment;
• Has previously been enrolled in and completed this study;
• Has any known allergy to one or more of the ingredients of the Investigational Product or to any other contrast media;
• Is determined by the Investigator that the subject is clinically unsuitable for the study;
• Has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment;
• Has history of surgery to the ovaries or pelvic inflammatory disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigia Storto, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics

Locations

Stanford University Medical Center

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BR55-109

Identifier Type: -

Identifier Source: org_study_id