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Ultrasound with BR55 for Pancreatic 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
Has at least one solid pancreatic lesion
Is at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights
Study Summary
This trial is testing a new way to look at pancreatic tumors using ultrasound. It is open to people who are suspected of having pancreatic cancer.
Who is the study for?
This trial is for adults with at least one solid pancreatic lesion suspected to be pancreatic ductal adenocarcinoma (PDAC), who are scheduled for surgery within 24 hours to 30 days after the study drug BR55 is given. Participants must consent and follow study rules. Exclusions include other cancers, prior PDAC therapy, severe hypertension or heart issues, open wounds in chest/abdomen/pelvis, certain vascular conditions like macular degeneration, pregnancy/lactation, recent major surgery or pancreas surgery.Check my eligibility
What is being tested?
The trial tests a new ultrasound contrast agent called BR55 used during transabdominal ultrasound to better characterize solid pancreatic lesions in patients suspected of having PDAC. It's an early-phase study where participants receive varying doses of BR55 before their planned surgeries.See study design
What are the potential side effects?
Potential side effects of BR55 aren't detailed here but may include allergic reactions due to ingredients in the contrast agent or typical risks associated with contrast media such as nausea or a warm feeling when injected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one solid tumor in my pancreas.
Select...
I am 18 years old or older.
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
1. Visual assessment of enhancement
2. Adverse Events
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
3Treatment groups
Experimental Treatment
Group I: 0.08mL/kg Dose GroupExperimental Treatment1 Intervention
A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.
Group II: 0.05mL/kg Dose GroupExperimental Treatment1 Intervention
A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.
Group III: 0.03mL/kg Dose GroupExperimental Treatment1 Intervention
A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/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
11,359 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,575 Total Patients Enrolled
Maria Luigia Storto, MDStudy DirectorBracco Diagnostics, Inc
4 Previous Clinical Trials
156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had another type of cancer at the same time.I have a serious heart condition.I am scheduled for surgery to remove a suspected pancreatic cancer within 30 days after receiving BR55.I have not had severe heart rhythm problems in the last week.I have open or non-healing wounds in my chest, abdomen, or pelvis.I have conditions like macular degeneration that could affect study results.I have at least one solid tumor in my pancreas.I have severe high blood pressure in my lungs or uncontrolled high blood pressure.I am 18 years old or older.I have recent issues with my pancreas, like pancreatitis or injury.I have had surgery on my pancreas.I have not had major surgery in the last 3 months.I have received treatment for pancreatic cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: 0.03mL/kg Dose Group
- Group 2: 0.05mL/kg Dose Group
- Group 3: 0.08mL/kg Dose Group
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.
Has the 0.08mL/kg Dose Group been validated by the FDA?
"The safety of 0.08mL/kg Dose Group was estimated to be a 2 on our team's scale, as the information available is limited and does not showcase efficacy in Phase 2 trials yet."
Answered by AI
Is the process of enrolling participants in this trial still underway?
"Unfortunately, the clinical trial listed on clinicaltrials.gov is not currently seeking new patients. This research was first posted in July 2018 and most recently updated 8th August 2023; however, there are a multitude of other trials recruiting now with over 800 studies available for participation."
Answered by AI
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