Clinical trial · Observational
The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis
- 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)
Systemic amyloidosis is a multi-system disease caused by extracellular deposition of insoluble amyloid fibrils in various tissues and organs, leading to progressive organ dysfunction. The clinical manifestations of different types of amyloidosis are complex and diverse, and the prognosis is very poor. Early detection and classification of amyloid deposition is becoming increasingly important. However, conventional imaging techniques including ultrasound and magnetic resonance are not sensitive or specific. Endocardial biopsy is the gold standard for the diagnosis of cardiac amyloidosis, but it is an invasive procedure with a clinical complication rate of 6%. Positron emission tomography (PET) provides a valuable tool for diagnosing systemic amyloidosis. Recently, amyloid PET imaging agents (11C-PIB or 18F-florbetapir) have been shown to be effective as novel positron tracers to detect potential amyloid deposition in some small sample studies. The investigators will use the most advanced imaging equipment, integrated PET/MR with amyloid PET imaging agents(11C-PIB or 18F-florbetapir) to image patients suspected or confirmed systemic amyloidosis, the aim is to explore the value of hybrid PET/MR for systemic amyloidosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PET/MR | — | UNRESOLVED | — |
| Systemic Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 11C-PIB or 18F-florbetapir PET/MR after treatment | Diagnostic Test | — | UNRESOLVED |
| 11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 11C-PIB or 18F-florbetapir PET/MR
- description
- Patients suspected of or diagnosed with systemic amyloidosis will be scanned by 11C-PIB or 18F-florbetapir PET/MR twice. One is before biopsy and treatment, and the other is after at least half a year of treatment.
- interventionNames
- Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment
- Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR after treatment
Primary outcomes (1)
- measure
- Sensitivity and specificity per patient analysis
- timeFrame
- up to 2 years
- description
- For patient without any treatment, detection and initial diagnosis, results of 11C-PiB or 18F-florbetapir PET/MR will be compared to histopathological, clinical, laboratory, radiological evidence and follow-up result.
Secondary outcomes (3)
- measure
- Sensitivity and specificity per organ analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patient with Monoclonal Ganunopathy, adds one of the following criteria: * Histologically confirmed Amyloidosis of any organ. * Average left ventricular thickness of the echocardiogram is more than 11 mm without uncontrolled high blood pressure. * 12-lead ECG shows unexplained low voltage \<0.5 mV. Exclusion Criteria: * Patient can not lie flat * NYHA Level 4 Heart Failure * Patient is pregnant or nursing * Patient is allergic to amyloid PET imaging agents * Patient with acute systemic diseases and electrolyte disorders * Patient with severe claustrophobia or unstable vital sigh * Other serious comorbidities evaluated by primary investigator
References
Publications (0)
Data not yet available