BR55 in Characterization of Ovarian Lesions

NCT03493464 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BR55-108
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory phase II, single center, open label, prospective study of BR55 CEUS for characterization of ovarian lesions in subjects with suspected ovarian cancer.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Visual Assessment of BR55 Enhancement

  BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement=no focal targeted, stationary imaging signal was detectable; weak enhancement=weak focal targeted imaging signal was detectable and considered possibly stationary; strong enhancement=well-defined and strong focal targeted imaging signal was detectable and considered as definitely stationary).

  30 minutes post-dose on Day 1

• Adverse Events

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

  2 days (day of and 24 hours after BR55 administration)

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg.

Drug: BR55

Interventions

BR55 DRUG

A novel targeted ultrasound contrast agent

Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years of age;
• Has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound;
• Is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier than 24 hours and not later than 30 days following BR55 administration;
• 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),
• by post-menopausal status with a minimum 1 year without menses;
• 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, such as macular degeneration, 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;

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

• Maria Luigia Storto, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Model Details: A total of sixty (60) subjects will be evaluated in the study. The first 10 subjects enrolled in the study will receive BR55 at a dose of 0.03 mL/kg. Assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 mL/kg dose of BR55; otherwise, subjects will be switched to a 0.05 mL/kg dose of BR55.

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 10, 2018
• Study Start: December 13, 2018
• Primary Completion: April 15, 2021
• Study Completion: July 31, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)