Clinical trial · Interventional
Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging
Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Monoclonal Gammopathy | — | UNRESOLVED | — |
| Monoclonal Gammopathy of Undetermined Significance (MGUS) | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Systemic Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ¹⁸F-florbetaben | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Monoclonal Gammopathy, Amyloid-Negative
- description
- Patients with monoclonal gammopathy, biopsy-negative for amyloid (negative controls)
- interventionNames
- Drug: ¹⁸F-florbetaben
- type
- OTHER
- label
- Monoclonal Gammopathy, Amyloid-Positive
- description
- Patients with monoclonal gammopathy, biopsy-positive for amyloid (study cohort)
- interventionNames
- Drug: ¹⁸F-florbetaben
- type
- OTHER
- label
- AL Amyloidosis
- description
- Patients with biopsy-proven AL amyloidosis (positive controls, with and without cardiomyopathy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participation in the COSMO-AL study * Available biopsy test result * Written informed consent Exclusion Criteria: * Pregnant or lactating women
References
Publications (0)
Data not yet available