Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

NCT07624760 | Not Yet Recruiting DMC

• 1 other identifier: 2026-00173
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

MGUS; MGCS; Amyloid PET; PET/MRI; Florbetaben; Early detection; Systemic amyloidosis; Monoclonal gammopathy; AL amyloidosis

Outcome Measures

Primary Outcomes (1)

• Systemic ¹⁸F-florbetaben PET positivity rate

  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.

  At time of PET/MR imaging (Day 1)

Secondary Outcomes (2)

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

  At time of PET/MR imaging (Day 1)

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

  At time of PET/MR imaging (Day 1)

Study Arms (3)

Monoclonal Gammopathy, Amyloid-Negative

OTHER

Patients with monoclonal gammopathy, biopsy-negative for amyloid (negative controls)

Drug: ¹⁸F-florbetaben

Monoclonal Gammopathy, Amyloid-Positive

OTHER

Patients with monoclonal gammopathy, biopsy-positive for amyloid (study cohort)

Drug: ¹⁸F-florbetaben

AL Amyloidosis

OTHER

Patients with biopsy-proven AL amyloidosis (positive controls, with and without cardiomyopathy)

Drug: ¹⁸F-florbetaben

Interventions

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

Also known as: Neuraceq, Florbetaben

AL Amyloidosis; Monoclonal Gammopathy, Amyloid-Negative; Monoclonal Gammopathy, Amyloid-Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating women

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance; Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hypergammaglobulinemia; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dominik C Benz, PD Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik C Benz, PD Dr. med.

CONTACT

+41432531191; dominik.benz@usz.ch

Mirjam Marty

CONTACT

mirjam.marty@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, observational cohort study, which will include three predefined patient groups: negative controls, study cohort, positive controls

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)