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NCT07624760Not yet recruiting

Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

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)

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
28 May 2026
Start date
Oct 2026
Primary completion date
May 2028
Lead sponsor
University of Zurich
NCT number
NCT07624760

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From Oct 2026 to the primary completion date, May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Pregnant or lactating women

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Zurich
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.