An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis

FBB-02-01-21

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.

2023-01-13

2025-03-01

2025-06-01

Recruiting

Early phase I

200

Inclusion Criteria: * Males and females age ≥18 years * Able to understand, sign and date written informed consent * Written informed consent must be obtained before any assessment is performed * Subjects being considered for a possible diagnosis of cardiac amyloidosis by * 1. One of the following conditions: * Established systemic amyloidosis without proven cardiac involvement, * Known plasma cell dyscrasia (MGUS, multiple myeloma), * Pathological free light chain levels in urine or serum, * Presence of heart failure with preserved ejection fraction * 2. AND one of the following parameters, indicative of cardiac manifestation: * Mean (left ventricular (LV) wall + septum) thickness \>12mm as measured by echocardiography in absence of other known cause of left ventricular hypertrophy (LVH), * NT-proBNP \>335 ng/L * Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy) * Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they must commit to use of a highly effective contraceptive measure for at least one week following the PET scan * Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following the PET scan * Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan Exclusion Criteria: * Any known allergic reactions or hypersensitivity towards any compound of the study drug * Severe hepatic impairment (AST/ALT \>5 x ULN; bilirubin \>3 x ULN) * Inability to lay flat for up to 60 min * Pregnant, lactating or breastfeeding * Unwilling and/or unable to cooperate with study procedures * Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All eligible patients will receive a single administration of the imaging agent \\[18F\\]florbetaben at a radioactive dose of 300 MBq.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-04-12