The goal of this clinical trial is to evaluate whether ¹⁸F-florbetaben PET/MR can detect systemic amyloid deposits early and noninvasively in patients with monoclonal gammopathy. The main question it aims to answer is: Can ¹⁸F-florbetaben PET/MR identify systemic amyloid deposits across clinically and histologically defined patient groups?
Participants will:
* Be screened for eligibility and asked to sign an informed consent form * Have their vital signs measured * Receive a single intravenous injection of approximately 300 MBq ¹⁸F-florbetaben (Neuraceq®), followed by whole-body PET/MR imaging from skull base to below the kidneys. If MRI is contraindicated (e.g., pacemaker, severe claustrophobia), PET/CT will be performed instead. The scan takes approximately one hour, during which participants lie still in the scanner * Be monitored during and after the scan for any side effects or adverse events * Complete study participation at the end of the imaging session (single visit, no follow-up required)
Participation in the COSMO-AL study
Available biopsy test result
Written informed consent
Pregnant or lactating women
Single group
¹⁸F-florbetaben
DrugSingle intravenous dose of \~300 MBq ¹⁸F-florbetaben followed by PET/MR (or PET/CT, if MRI is contraindicated), from the skull base to below the kidneys
Systemic ¹⁸F-florbetaben PET positivity rate
Rate of positive ¹⁸F-florbetaben PET scans assessed by visual qualitative analysis across the three patient groups (monoclonal gammopathy without biopsy-proven amyloid, biopsy-positive monoclonal gammopathy, biopsy-proven systemic AL). PET positivity is defined as any tracer uptake in the myocardium or in any organ outside the liver. Imaging performed with PET/MR or PET/CT, if MRI is contraindicated.
Correlation of myocardial ¹⁸F-Florbetaben uptake with cardiac biomarker and MRI parameters
Correlation of myocardial percent injected dose (%ID) with NT-proBNP (pg/mL) and cardiac MR parameters (indexed LV mass (g/m²), left ventricular ejection fraction (LVEF, %), and extracellular volume fraction (ECV, %)
Association of Myocardial ¹⁸F-Florbetaben Uptake with Histological Amyloid Status
Association of myocardial %ID with histological amyloid status (positive vs. negative) as determined by biopsy data from the parallel COSMO-AL study cohort.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
