BR55 in Characterization of Ovarian Lesions

BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: BR55

Detailed Description

A total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of BR55 CEUS examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the truth standard (TS).

The first 10 subjects 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.

The final cancer diagnosis will be obtained for all subjects by histopathology.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Enroll a subject if he/she meets the following inclusion criteria:

• 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.

Exclusion Criteria: Exclude a subject if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:

• 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;
• Has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment;
• Has history of surgery to the ovaries or pelvic inflammatory disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg.	Drug: BR55; A novel targeted ultrasound contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Collaborators: National Institutes of Health (NIH)
• Investigators: Study Director: Maria Luigia Storto, MD, Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BR55-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No