Optimal Timing of BR55 CEUS of the Ovaries

NCT04248153 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BR55-109
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of participants who received the contrast agent and experienced an adverse event.

  From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: BR55

Group B

EXPERIMENTAL

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

Drug: BR55

Interventions

BR55 DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female subject of at least 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Giordana Marioni, Clinical Trial Assistant
• Organization: Bracco Diagnostics Inc.

giordana.marioni@diag.bracco.com

609-514-2282

Study Officials

• Luigia Storto, MD

  Bracco Diagnostics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group A: BR55 CEUS will be performed in the early follicular phase first and in the late follicular phase thereafter; Group B: BR55 CEUS will be performed in the late follicular phase first and in the early phase thereafter.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: October 14, 2019
• Primary Completion: February 19, 2020
• Study Completion: July 31, 2021
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)