Life Molecular Imaging GmbH
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.
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 or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement. The diagnostic efficacy of the visual and quantitative assessments of \[18F\]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will…
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 study procedures are 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 foll…
All enrolled patients will undergo \[18F\]florbetaben PET imaging.