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BR55 Ultrasound for Ovarian Cancer
Phase 2
Waitlist Available
Research Sponsored by Bracco Diagnostics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is premenopausal
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of signing informed consent through 24 hrs post dose follow up evaluation
Awards & highlights
Study Summary
This trial is testing a new ultrasound technique to see if it can more accurately detect ovarian cancer in high-risk women.
Who is the study for?
This trial is for premenopausal women at least 18 years old who are at high risk for ovarian cancer and scheduled for preventative surgery. They must be able to follow the study's procedures and provide consent. Women can't join if they're pregnant, breastfeeding, have severe heart issues or rhythm disorders, recently had major surgery, or have been in another trial within the last month.Check my eligibility
What is being tested?
The study is testing BR55 contrast-enhanced ultrasound (CEUS) to find out when during the menstrual cycle it's best to image ovaries in women with a high genetic risk of ovarian cancer before their preventative surgery.See study design
What are the potential side effects?
Potential side effects of BR55 CEUS may include allergic reactions to its ingredients or other contrast media used in imaging tests. Specific side effects aren't listed but would typically relate to how the body responds to foreign substances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not gone through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of signing informed consent through 24 hrs post dose follow up evaluation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of signing informed consent through 24 hrs post dose follow up evaluation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Visual assessment of enhancement
Side effects data
From 2016 Phase 1 & 2 trial • 19 Patients • NCT021426086%
Headache
6%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
BR55
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.
Group II: Group AExperimental Treatment1 Intervention
BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BR55
2014
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,594 Total Patients Enrolled
13 Trials studying Ovarian Cancer
970 Patients Enrolled for Ovarian Cancer
Bracco Diagnostics, IncLead Sponsor
60 Previous Clinical Trials
11,360 Total Patients Enrolled
1 Trials studying Ovarian Cancer
14 Patients Enrolled for Ovarian Cancer
Luigia Storto, MDStudy DirectorBracco Diagnostics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 3 months.I am scheduled for surgery to remove my ovaries and fallopian tubes due to a high risk of ovarian cancer within 5 days after my second BR55 CEUS exam.I am a woman and I am 18 years old or older.I have not had severe heart rhythm problems in the last week.I have severe high blood pressure in my lungs or uncontrolled high blood pressure.I have had surgery on my ovaries or had pelvic inflammatory disease.I have not gone through menopause.You have other blood vessel problems that could make it difficult to assess the effects of BR55.I have had another type of cancer at the same time.You have allergies to any of the ingredients in the experimental treatment or to other substances used for medical imaging.I have a serious heart condition.I have received treatment for ovarian cancer before.I have open or non-healing wounds in my chest, abdomen, or pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Group B
- Group 2: Group A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for prospective participants in this clinical experiment?
"Clinicaltrials.gov indicates that, as of 8/8/2023, this particular study is no longer accepting participants. Although it was initially posted on 10/14/2019 the trial has since been closed to new patients; however there are 406 other trials currently enrolling individuals at this time."
Answered by AI
To what extent might individuals be endangered by Group B?
"Our team's assessment of Group B is a 2, due to the fact that this Phase 2 trial has collected some data on safety but not yet any evidence to suggest efficacy."
Answered by AI
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