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Contrast Agent
BR55 Ultrasound for Ovarian Lesions
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
Study Summary
This trial is testing if using a special kind of ultrasound can help doctors better understand ovarian lesions in people suspected of having ovarian cancer.
Who is the study for?
This trial is for adults with visible ovarian lesions who are scheduled for ovary removal surgery due to suspected cancer. They must be able to follow the study rules and give informed consent. People can't join if they've had prior ovarian cancer treatment, severe heart or lung conditions, certain vascular issues, allergies to BR55 ingredients or contrast media, recent major surgery, concurrent malignancy, or are pregnant.Check my eligibility
What is being tested?
The study tests BR55 in an ultrasound procedure (CEUS) on patients with suspected ovarian cancer to see how well it helps characterize ovarian lesions. It's a phase II trial where participants receive the investigational product before their planned surgery.See study design
What are the potential side effects?
Potential side effects of BR55 aren't detailed here but may include reactions related to contrast agents such as allergic responses or discomfort at the injection site. The exact side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
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
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Subjects will receive a single dose of BR55 at 0.03 mL/kg or 0.05 mL/kg.
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?
Bracco Diagnostics, IncLead Sponsor
60 Previous Clinical Trials
11,349 Total Patients Enrolled
1 Trials studying Ovarian Cancer
3 Patients Enrolled for Ovarian Cancer
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,566 Total Patients Enrolled
13 Trials studying Ovarian Cancer
959 Patients Enrolled for Ovarian Cancer
Maria Luigia Storto, MDStudy DirectorBracco Diagnostics, Inc
4 Previous Clinical Trials
146 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment for ovarian cancer in the past.You have very high blood pressure in your lungs or uncontrolled high blood pressure throughout your body, or you have a severe breathing problem.You have other conditions that affect blood vessels and could make it hard to assess the effects of BR55.You have an allergy to any of the ingredients in the study drug or any other contrast media.You have wounds in the chest, abdomen, or pelvis that are not healing.You have had another type of cancer at the same time or in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
What safety precautions have been taken to ensure the efficacy of BR55 for those using it?
"BR55's safety is rated a 2 since there are data indicating its security but not yet any proof of its efficacy."
Answered by AI
Is enrollment into the research currently available to participants?
"Clinicaltrials.gov has reported that this clinical trial is no longer enrolling patients, which was last updated on July 31st 2023 after its publication date of December 13th 2018. Despite the lack of current recruitment for this particular medical study, there are 404 other trials currently open for patient participation."
Answered by AI
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