Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT06400004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lumason® Infusion vs. Bolus Administrations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013535', 'term': 'Suspensions'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate LV EBD Score', 'timeFrame': '2-3 Hours', 'description': '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.'}, {'measure': 'Adequate LV Opacification', 'timeFrame': '2-3 Hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Clinically useful LVO', 'timeFrame': '2-3 Hours', 'description': 'To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration'}, {'measure': 'Adverse events', 'timeFrame': '24 Hours', 'description': 'Compare adverse event rate after infusion vs. bolus administrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are at least 18-years old;\n* Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;\n* Provide their written informed consent and are willing to comply with protocol requirements.\n\nExclusion Criteria:\n\n* Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);\n* Patient has uncontrolled angina (i.e., uncontrolled on medication);\n* Patient had a recent myocardial infarction (within the last 3 days and not stabilized);\n* Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;\n* Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;\n* Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;\n* Has any known allergy to one or more of the ingredients of the investigational product;\n* 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;\n* Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;\n* Is determined by the Investigator that the patient is clinically unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT06400004', 'briefTitle': 'Lumason® Infusion vs. Bolus Administrations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracco Diagnostics, Inc'}, 'officialTitle': 'A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography', 'orgStudyIdInfo': {'id': 'BR1-149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bolus administration', 'description': 'Bolus administration of 2 mL undiluted Lumason®', 'interventionNames': ['Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous infusion', 'description': 'Continuous infusion of 8 mL of diluted Lumason®', 'interventionNames': ['Drug: Lumason']}], 'interventions': [{'name': 'Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]', 'type': 'DRUG', 'otherNames': ['Bolus Administration'], 'description': 'Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds', 'armGroupLabels': ['Bolus administration']}, {'name': 'Lumason', 'type': 'DRUG', 'otherNames': ['Infusion Administration'], 'description': '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', 'armGroupLabels': ['Continuous infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Caryn Bernstein', 'role': 'CONTACT', 'email': 'caryn.bertstein@piedmont.org', 'phone': '404-605-5688'}, {'name': 'Venkateshwar Polsani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Constance Angell-James, MPH', 'role': 'CONTACT', 'email': 'cangellj@bidmc.harvard.edu'}, {'name': 'Madeline Cassidy', 'role': 'CONTACT', 'email': 'mcassid6@bidmc.harvard.edu'}, {'name': 'Jordan Strom, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'contacts': [{'name': 'Kevin Wei, MD', 'role': 'CONTACT', 'email': 'weik@ohsu.edu', 'phone': '503-494-7400'}, {'name': 'Kevin Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health and Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Rushil Sankpal', 'role': 'CONTACT', 'email': 'rushil.sankpal@diag.bracco.com', 'phone': '609-514-2267'}, {'name': 'Audrey Sahns', 'role': 'CONTACT', 'email': 'audrey.sahns@diag.bracco.com', 'phone': '610-357-1734'}], 'overallOfficials': [{'name': 'Jose Banchs, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sr. Medical Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}