Optimal Timing of BR55 CEUS of the Ovaries

Sponsor

Bracco Diagnostics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT04248153

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

23.6

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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 CEUS of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: BR55	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women

Actual Study Start Date :

Oct 14, 2019

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.	Drug: BR55 BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg
Experimental: Group B BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.	Drug: BR55 BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg

Arm

Intervention/Treatment

Experimental: Group A

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

Drug: BR55

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

Experimental: Group B

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

Drug: BR55

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

Outcome Measures

Primary Outcome Measures

Visual assessment of enhancement [1 day]
BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).
Adverse Events [from the time of signing Informed Consent through 24 hrs post dose follow up evaluation]
Number of participants who received the contrast agent and experienced an adverse event.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria: Enroll a subject in this study if the subject meets the following inclusion criteria:

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.

Exclusion Criteria: Exclude a subject from this study 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),
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;
Has history of surgery to the ovaries or pelvic inflammatory disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Palo Alto	California	United States	94304

Sponsors and Collaborators

Bracco Diagnostics, Inc
National Institutes of Health (NIH)

Investigators

Study Director: Luigia Storto, MD, Bracco Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bracco Diagnostics, Inc

ClinicalTrials.gov Identifier:

NCT04248153

Other Study ID Numbers:

BR55-109

First Posted:

Jan 30, 2020

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 2, 2022