Clinical trial NCT06400004: Lumason® Infusion vs. Bolus Administrations
Official title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Heart Diseases
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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.

Primary outcomes:
measure: Adequate LV EBD Score
timeFrame: 2-3 Hours
measure: Adequate LV Opacification
timeFrame: 2-3 Hours
Secondary outcomes:
measure: Clinically useful LVO
timeFrame: 2-3 Hours
measure: Adverse events
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
Study officials:
affiliation: Sr. Medical Director
name: Jose Banchs, MD
role: STUDY_DIRECTOR
References: