Lumason® Infusion vs. Bolus Administrations
Bracco Diagnostics, Inc · NCT06400004
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 106
- US sites recruiting
- 4
- Study start
- July 10, 2024
- Record last updated
- October 20, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Being studied: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]; Lumason
Conditions: Heart Diseases
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Are at least 18-years old;
- Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
- Provide their written informed consent and are willing to comply with protocol requirements.
Exclusion Criteria
- Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
- Patient has uncontrolled angina (i.e., uncontrolled on medication);
- Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
- Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;
- Has any known allergy to one or more of the ingredients of the investigational product;
- Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses;
- Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;
- Is determined by the Investigator that the patient is clinically unsuitable for the study.
Recruiting US locations
Interventional Cardiology Medical Group
West Hills, CA 91307
Site contact: Michael Fam, MD · 818-743-0666 · mfam@elegantrd.com
Piedmont Heart Institute
Atlanta, GA 30309
Site contact: Suzanne Corley · 404-605-3118 · suzanne.corley@piedmont.org
Beth Israel Deaconess Medical Center
Boston, MA 02215
Site contact: Constance Angell-James, MPH · cangellj@bidmc.harvard.edu
Vital Heart and Vein
Humble, TX 77338
Site contact: Ovee Muhebb · 281-572-0109 · s.muhebb@vitalheartandvein.com
Study contacts (from the official record)
- Rushil Sankpal · 609-514-2267 · rushil.sankpal@diag.bracco.com
Similar studies in California
All heart & blood pressure studies in California →- RecruitingHealthy volunteersPhase 1/Phase 2
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Novartis Pharmaceuticals
- Location
- Orange, CA + 18 other US sites
- Eligibility basics
- Ages 18–100
- RecruitingHealthy volunteersPhase 1/Phase 2
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions
Thomas Advanced Medical LLC
- Location
- Culver City, CA
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteersEarly Phase 1
Single-tracer Multiparametric PET Imaging
University of California, Davis
- Location
- Sacramento, CA
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteers
BoxX-NoAF Clinical Trial
AtriCure, Inc.
- Location
- San Diego, CA + 30 other US sites
- Eligibility basics
- Ages 65+