Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT04535193
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C107924', 'term': '3-fluorobenzylguanidine'}, {'id': 'D061605', 'term': 'Administration, Intravenous'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Study Cohort I will evaluate the myocardial update of 18F-mFBG (as a marker of sympathetic innervation) in control subject with a low likelihood of coronary heart disease.\n\nStudy Cohort II will evaluate the myocardial update of 18F-mFBG (as a marker of sympathetic innervation) in stable patients with heart failure and reduced left ventricular function'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-30', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chang in 18F-mFBG uptake', 'timeFrame': 'Up to 210 minutes after dosing', 'description': 'Change in 18F-mFBG uptake in the total body and the normal heart over time (based on serial PET images) to:\n\n* document the time course of global and regional myocardial activity reflecting specific uptake and clearance of the radiopharmaceutical;\n* estimate individual organ and whole-body radiation dosimetry.'}, {'measure': 'Evaluation of 18F-mFBG for imaging myocardial sympathetic innervation', 'timeFrame': 'Up to 100 minutes after dosing', 'description': 'To demonstrate the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of HF subjects with significant LV dysfunction (LVEF≤35%).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18F-mFBG', 'meta-fluorobenzylguanidine'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.', 'detailedDescription': 'This is a Phase 1/2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The first part of the study will examine control subjects, patients with very low likelihood of coronary heart disease. This initial part will determine optimal imaging procedures for studying uptake and clearance of 18F-mFBG in myocardial sympathetic neurons and provide preliminary data for estimating radiation dosimetry in adults and developing reference files for quantification of normal and abnormal levels of the radiopharmaceutical. The second part will examine a group of stable patients with New York Heart Association (NYHA) class 2 heart failure (HF) and reduced left ventricular (LV) systolic function (LV ejection fraction (EF) ≤35%). The primary objectives of the second part will be to:\n\n* document the degree to which 18F-mFBG uptake in the heart is reduced and\n* characterize the distribution of regional abnormalities in relation to findings on other cardiac imaging studies such as myocardial perfusion (MP) and magnetic resonance (MR) imaging.\n\nEffectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years of age at study entry\n* able and willing to comply with study procedures\n* signed and dated informed consent is obtained\n* male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.\n\nFor control subjects:\n\n* Subject is either:\n\n * \\<40 years old and has a likelihood assessment for CAD \\<10%, or\n * 40-50 years old, has a likelihood assessment for CAD \\<10%, and a normal stress MPI study or stress echocardiography performed within 6 months before study entry, or\n * Without significant coronary atherosclerotic disease (no arterial stenosis with \\>30% narrowing) as demonstrated by a coronary angiography performed with 6 months before study entry.\n\nFor heart failure subjects:\n\n* Diagnosed with HF at least 1 year before enrollment.\n* HF classification NYHA Class II at enrollment.\n* Rest left ventricular ejection fraction (LVEF) ≤35% measured by an appropriate method (e.g., radionuclide or contrast ventriculography, ECG-gated SPECT MPI, or echocardiography) within 180 days prior to the study imaging procedure, with no change in clinical condition since the LVEF measurement.\n* Primary prevention ICD, implanted at least 6 months before enrollment.\n* Clinically stable for at least 30 days before enrollment (e.g., not experiencing continuing chest pain, hemodynamic instability, or clinically significant arrhythmia (including ICD discharge)) and remains stable to the time of the study imaging procedure.\n\nExclusion Criteria:\n\n* Previously entered into this study or has participated in any other investigational medicinal product or medical device study within 30 days of enrollment.\n* History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.\n* Ventricular pacemaker that routinely functions (\\>5% paced beats)\n* Cardiac revascularization (e.g., percutaneous transluminal coronary angioplasty, PCI, or CABG), or an acute myocardial infarction within the past 30 days.\n* Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.\n* Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.\n* Claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to an hour at a time.\n* Renal insufficiency (serum creatinine \\>3.0 mg/dL).\n* Use of medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.\n* Participated in a research study using ionizing radiation in the previous 12 months.\n* For control subjects: a history of Type I or Type II Diabetes Mellitus, signs/symptoms of neurological disease (e.g., Parkinson's Disease, Multiple System Atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system."}, 'identificationModule': {'nctId': 'NCT04535193', 'briefTitle': 'Open-Label Study of 18F-mFBG for Imaging Myocardial Sympathetic Innervation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)'}, 'officialTitle': 'An Open-Label, Exploratory, Phase 1/2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects Without and With Heart Disease', 'orgStudyIdInfo': {'id': 'IRP101-121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low likelihood of coronary heart disease', 'description': 'Thorax and total body imaging for quantification of normal biodistribution and myocardial sympathetic innervation. PET imaging to 210 minutes post-administration.', 'interventionNames': ['Drug: 18F-mFBG for intravenous administration']}, {'type': 'OTHER', 'label': 'Heart Failure + left ventricular function (LVEF ≤ 35%)', 'description': 'Thorax and total body imaging for quantification of myocardial sympathetic innervation. PET imaging to 100 minutes post-administration', 'interventionNames': ['Drug: 18F-mFBG for intravenous administration']}], 'interventions': [{'name': '18F-mFBG for intravenous administration', 'type': 'DRUG', 'otherNames': ['meta-fluorobenzylguanidine', 'IRP101'], 'description': 'Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent', 'armGroupLabels': ['Heart Failure + left ventricular function (LVEF ≤ 35%)', 'Low likelihood of coronary heart disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Morningside', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Vikram Agarwal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Morningside'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mount Sinai Hospital, New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}