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NCT07624760Not yet recruiting

Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

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)

Inclusion criteria

• Participation in the COSMO-AL study • Available biopsy test result • Written informed consent

Exclusion criteria

• Pregnant or lactating women

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Not yet recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland
Sponsor
University of Zurich(Other)
Protocol no.
2026-00173
Conditions
Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Significance (MGUS), Multiple Myeloma, AL Amyloidosis, Systemic Amyloidosis
Interventions
Drug

Treatments studied

  • ¹⁸F-florbetaben

Locations · 1

  • Zurich, SwitzerlandUniversity Hospital ZurichNot yet recruiting at this site

In total, worldwide, the only site listed in the registry is planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: June 3, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.