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Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging
Sponsor: University of Zurich
Summary
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)
Official title: Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-10
Completion Date
2028-05
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
¹⁸F-florbetaben
Single 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
Locations (1)
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland