BR55 in Characterization of Ovarian Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: BR55


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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