Recruiting
Phase 3

Lumason

Sponsor:

Bracco Diagnostics, Inc

Code:

NCT06400004

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

Lumason

Study Details

Brief summary:

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).

Conditions

Heart Diseases

Study ID

NCT06400004

Start date

Jul 10, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Bolus administration

Bolus administration of 2 mL undiluted Lumason®

experimental: Continuous infusion

Continuous infusion of 8 mL of diluted Lumason®

Interventions

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds

Lumason

Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min

Primary outcome measure

  • Adequate LV EBD Score [ Time Frame: 2-3 Hours ]
  • Adequate LV Opacification [ Time Frame: 2-3 Hours ]

Central Contacts and Locations

Central contacts

Rushil Sankpal

609-514-2267rushil.sankpal@diag.bracco.com

Locations

Interventional Cardiology Medical Group

Recruiting

West Hills, California, United States, 91307

Contacts

Michael Fam, MD

818-743-0666mfam@elegantrd.com

Principal Investigator:

Farhad Rafii, MD

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Suzanne Corley

404-605-3118suzanne.corley@piedmont.org

Principal Investigator:

Venkateshwar Polsani, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Constance Angell-James, MPH

cangellj@bidmc.harvard.edu

Madeline Cassidy

mcassid6@bidmc.harvard.edu

Principal Investigator:

Jordan Strom, MD

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

Contacts

Ovee Muhebb

281-572-0109s.muhebb@vitalheartandvein.com

Principal Investigator:

Patrick Kee, MD

More Information

Sponsor

Bracco Diagnostics, Inc

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bracco Diagnostics, Inc on 2026-03-05.