BR55 in Characterization of Ovarian Lesions

• ClinicalTrials.gov Identifier: NCT03493464
• Recruitment Status: Completed
• First Posted: April 10, 2018
• Last Update Posted: March 2, 2022
• Sponsor: Bracco Diagnostics, Inc
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Bracco Diagnostics, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: BR55	Phase 2

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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions
• Actual Study Start Date: December 13, 2018
• Actual Primary Completion Date: August 1, 2021
• Actual Study Completion Date: October 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Visual assessment of enhancement [ Time Frame: 1 Day ]
   BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
2. Adverse Events [ Time Frame: 2 Days ]
   Number of participants who received the contrast agent and experienced an adverse event.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female only
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Stanford University Medical Center

Palo Alto, California, United States, 94304

Sponsors and Collaborators

Bracco Diagnostics, Inc

National Institutes of Health (NIH)

Investigators

• Study Director: Maria Luigia Storto, MD; Bracco Diagnostics, Inc

More Information

• Responsible Party: Bracco Diagnostics, Inc
• ClinicalTrials.gov Identifier: NCT03493464
• Other Study ID Numbers: BR55-108
• First Posted: April 10, 2018
• Last Update Posted: March 2, 2022
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No