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Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

NCT07624760 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-03

No results posted yet for this study

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)

Conditions

  • Monoclonal Gammopathy
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Multiple Myeloma
  • AL Amyloidosis
  • Systemic Amyloidosis

Interventions

DRUG

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

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Dominik C Benz, PD Dr. med. · University of Zurich

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624760 on ClinicalTrials.gov