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Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging (MGUS-PET)

28. maj 2026 opdateret af: University of Zurich

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)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. Amyloid PET shows pathological tracer uptake in patients with AL amyloidosis and remains unremarkable in negative controls.
  2. Amyloid PET detects amyloid deposits at a stage in which conventional methods do not yet show structural or functional changes.
  3. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Schweiz
    • Canton of Zurich
      • Zurich, Canton of Zurich, Schweiz, 8091
        • University Hospital Zurich
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Dominik C Benz, PD Dr. med.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or lactating women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Monoclonal Gammopathy, Amyloid-Negative
Patients with monoclonal gammopathy, biopsy-negative for amyloid (negative controls)
Medicin: 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
Andre navne:
  • Neuraceq
  • Florbetaben
Andet: Monoclonal Gammopathy, Amyloid-Positive
Patients with monoclonal gammopathy, biopsy-positive for amyloid (study cohort)
Medicin: 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
Andre navne:
  • Neuraceq
  • Florbetaben
Andet: AL Amyloidosis
Patients with biopsy-proven AL amyloidosis (positive controls, with and without cardiomyopathy)
Medicin: 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
Andre navne:
  • Neuraceq
  • Florbetaben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Systemic ¹⁸F-florbetaben PET positivity rate
Tidsramme: 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.
At time of PET/MR imaging (Day 1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation of myocardial ¹⁸F-Florbetaben uptake with cardiac biomarker and MRI parameters
Tidsramme: 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, %)
At time of PET/MR imaging (Day 1)
Association of Myocardial ¹⁸F-Florbetaben Uptake with Histological Amyloid Status
Tidsramme: 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.
At time of PET/MR imaging (Day 1)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Efterforskere

  • Ledende efterforsker: Dominik C Benz, PD Dr. med., University of Zurich

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-00173

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Myelomatose

Kliniske forsøg med ¹⁸F-florbetaben

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