Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

Sponsor
University of Zurich
Study ID
NCT07624760
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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)

Key Dates

First listed
Jun 3, 2026
Start date
Oct 31, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Monoclonal Gammopathy, Amyloid-Negative
    Patients with monoclonal gammopathy, biopsy-negative for amyloid (negative controls)
  • Other: Monoclonal Gammopathy, Amyloid-Positive
    Patients with monoclonal gammopathy, biopsy-positive for amyloid (study cohort)
  • Other: AL Amyloidosis
    Patients with biopsy-proven AL amyloidosis (positive controls, with and without cardiomyopathy)

Primary Outcome Measure

Systemic ¹⁸F-florbetaben PET positivity rate [ Time Frame: At time of PET/MR imaging (Day 1) ]

Central Contacts

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