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NCT Number: NCT07624760

Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

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)

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Key information

Conditions

Monoclonal Gammopathy AL Amyloidosis Amyloidosis Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Monoclonal Gammopathy of Undetermined Significance (MGUS) Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies Systemic Amyloidosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location contact

Dominik C Benz, PD Dr. med.

CONTACT

[email protected]

+41432531191

Dominik C Benz, PD Dr. med.

PRINCIPAL_INVESTIGATOR

Mirjam Marty

CONTACT

[email protected]

About this study

Aim of the Project: The overarching goal is to establish a non-invasive, sensitive method for early detection of systemic amyloid deposits, laying the foundation for earlier diagnosis and improved treatment of AL amyloidosis.

  • Primary Aim: Validate 18F-florbetaben PET for detection of systemic AL amyloidosis versus negative controls.
  • Secondary Aim: Compare the sensitivity of amyloid PET with established methods (echocardiography, MRI, serological biomarkers) for the detection of early organ involvement.
  • Tertiary Aim: Quantify and characterize systemic amyloid burden across early and manifest disease stages.

Hypotheses:

  • Amyloid PET shows pathological tracer uptake in patients with AL amyloidosis and remains unremarkable in negative controls.
  • Amyloid PET detects amyloid deposits at a stage in which conventional methods do not yet show structural or functional changes.
  • Systemic amyloid burden follows a graded pattern, with intermediate values in early disease and the highest values in manifest AL amyloidosis.

Study Design and Methods Prospective, observational cohort study at the University Hospital Zurich (USZ). 50 participants will be recruited from the established COSMO-AL cohort at the Department of Hematology, which systematically captures patients with clinically significant monoclonal gammopathy and provides standardized skin biopsy data.

Participants:

  • Negative controls: monoclonal gammopathy without histologic amyloid (n = 10).
  • Early disease (study cohort): monoclonal gammopathy with local, histologically confirmed amyloid deposits (n = 20).
  • Positive controls: biopsy-confirmed systemic AL amyloidosis (n = 20). Patients with confirmed amyloid involvement will be additionally stratified by organ involvement to allow exploratory analysis of organ-specific tracer uptake.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant or lactating women

Treatment and study plan

¹⁸F-florbetaben

Drug

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

Other names: Neuraceq, Florbetaben

Primary outcomes

  1. Systemic ¹⁸F-florbetaben PET positivity rate

    Time frame: At time of PET/MR imaging (Day 1)

    Rate of positive ¹⁸F-florbetaben PET scans assessed by visual qualitative analysis across the three patient groups (monoclonal gammopathy without biopsy-proven amyloid, biopsy-positive monoclonal gammopathy, biopsy-proven systemic AL). PET positivity is defined as any tracer uptake in the myocardium or in any organ outside the liver. Imaging performed with PET/MR or PET/CT, if MRI is contraindicated.

Secondary outcomes

  1. Correlation of myocardial ¹⁸F-Florbetaben uptake with cardiac biomarker and MRI parameters

    Time frame: At time of PET/MR imaging (Day 1)

    Correlation of myocardial percent injected dose (%ID) with NT-proBNP (pg/mL) and cardiac MR parameters (indexed LV mass (g/m²), left ventricular ejection fraction (LVEF, %), and extracellular volume fraction (ECV, %)

  2. Association of Myocardial ¹⁸F-Florbetaben Uptake with Histological Amyloid Status

    Time frame: At time of PET/MR imaging (Day 1)

    Association of myocardial %ID with histological amyloid status (positive vs. negative) as determined by biopsy data from the parallel COSMO-AL study cohort.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik C Benz, PD Dr. med.

CONTACT

[email protected]

+41432531191

Mirjam Marty

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: MGUS-PET

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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