Lumason® Infusion vs. Bolus Administrations

A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases
• Intervention / Treatment: Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]; Drug: Lumason

Detailed Description

This is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rushil Sankpal; Phone Number: 609-514-2267; Email: rushil.sankpal@diag.bracco.com

Study Locations

• United States
  • California
    • West Hills, California, United States, 91307
      • Recruiting
      • Interventional Cardiology Medical Group
      • Principal Investigator: Farhad Rafii, MD
      • Contact: Michael Fam, MD; Phone Number: 818-743-0666; Email: mfam@elegantrd.com
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Heart Institute
      • Principal Investigator: Venkateshwar Polsani, MD
      • Contact: Suzanne Corley; Phone Number: 404-605-3118; Email: Suzanne.corley@piedmont.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Constance Angell-James, MPH; Email: cangellj@bidmc.harvard.edu
      • Contact: Madeline Cassidy; Email: mcassid6@bidmc.harvard.edu
      • Principal Investigator: Jordan Strom, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Oregon Health and Sciences University
      • Contact: Amy Koski; Phone Number: 503-360-6705; Email: koskia@ohsu.edu
      • Principal Investigator: David German, MD
      • Sub-Investigator: Brian Davidson, MD
  • Texas
    • Galveston, Texas, United States, 77555
      • Withdrawn
      • University of Texas Medical Branch
    • Humble, Texas, United States, 77338
      • Recruiting
      • Vital Heart and Vein
      • Contact: Ovee Muhebb; Phone Number: 281-572-0109; Email: s.muhebb@vitalheartandvein.com
      • Principal Investigator: Patrick Kee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bolus administration; Bolus administration of 2 mL undiluted Lumason®	Drug: 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; Other Names: Bolus Administration
Experimental: Continuous infusion; Continuous infusion of 8 mL of diluted Lumason®	Drug: 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; Other Names: Infusion Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate LV EBD Score	Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.	2-3 Hours
Adequate LV Opacification	Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.	2-3 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically useful LVO	To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration	2-3 Hours
Adverse events	Compare adverse event rate after infusion vs. bolus administrations	24 Hours

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Investigators: Study Director: Jose Banchs, MD, Sr. Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Suspensions
• Other Study ID Numbers: BR1-149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No