Monoclonal GammopathyMGUS-PETNCT07624760
Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging
A study testing ¹⁸F-florbetaben in people with Monoclonal Gammopathy and Monoclonal Gammopathy of Undetermined Significance (MGUS), run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Significance (MGUS), Multiple Myeloma
- What is being tested?
- ¹⁸F-florbetaben
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2026to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the COSMO-AL study
- Available biopsy test result
- Written informed consent
Who cannot join
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mirjam Marty contact
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Dominik C Benz, PD Dr. med., +41432531191, dominik.benz@usz.ch
Mirjam Marty, mirjam.marty@usz.ch
About this study
Official title: Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study
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)
Read the detailed description
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.
- Conditions
- Monoclonal Gammopathy, Monoclonal Gammopathy of Undetermined Significance (MGUS), Multiple Myeloma, AL Amyloidosis, Systemic Amyloidosis
- Being tested
- ¹⁸F-florbetaben
- Keywords
- MGUS, MGCS, Amyloid PET, PET/MRI, Florbetaben, Early detection, Systemic amyloidosis, Monoclonal gammopathy, AL amyloidosis
- Medical subject headings
- Paraproteinemias, Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¹⁸F-florbetabenDrug
Also called Neuraceq, 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
| Study group | Role | What they receive |
|---|---|---|
| Monoclonal Gammopathy, Amyloid-Negative | Other | Patients with monoclonal gammopathy, biopsy-negative for amyloid (negative controls) Receives: Drug: ¹⁸F-florbetaben |
| Monoclonal Gammopathy, Amyloid-Positive | Other | Patients with monoclonal gammopathy, biopsy-positive for amyloid (study cohort) Receives: Drug: ¹⁸F-florbetaben |
| AL Amyloidosis | Other | Patients with biopsy-proven AL amyloidosis (positive controls, with and without cardiomyopathy) Receives: Drug: ¹⁸F-florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of PET/MR imaging (Day 1)
Secondary outcomes (2)
Correlation of myocardial ¹⁸F-Florbetaben uptake with cardiac biomarker and MRI parameters
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, %)
Measured: At time of PET/MR imaging (Day 1)
Association of Myocardial ¹⁸F-Florbetaben Uptake with Histological Amyloid Status
Association of myocardial %ID with histological amyloid status (positive vs. negative) as determined by biopsy data from the parallel COSMO-AL study cohort.
Measured: At time of PET/MR imaging (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal GammopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single-center, prospective, observational cohort study, which will include three predefined patient groups: negative controls, study cohort, positive controls
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik C Benz, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624760
- Sponsor's protocol ID
- 2026-00173
- Acronym
- MGUS-PET
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as this is a single-center investigator-initiated study with a small sample size (n=50). Aggregate results will be published in a peer-reviewed journal.