Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

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)

Eligibility criteria

Qualifiers

Participation in the COSMO-AL study

Available biopsy test result

Written informed consent

Disqualifiers

Pregnant or lactating women

Trial design

Treatments tested in this trial

  • ¹⁸F-florbetaben

Treatment groups

50 Participants
are divided into 3 treatment groups

Sponsors and collaborators