Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis

Study Overview
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Brief Summary
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The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare these results to non-amyloid diseased controls.

Detailed Description
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Patients with pathologically proven amyloidosis involving the peripheral nervous system will undergo 18-F Florbetapir PET/MR on a GE (General Electric Healthcare) SIGNA PET/MR scanner. A control arm comprised of patients with pathologically-confirmed non-amyloid causes of peripheral neuropathy will also undergo 18-F Florbetapir PET/MR scanning. all images will be reviewed for peripheral nerve uptake.

Official Title
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Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis

Conditions
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Amyloidosis

Intervention / Treatment
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* Other: 18-F Florbetapir PET/MR scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults: 18-100 Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy Exclusion Criteria: Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.) Claustrophobia BMI over 38

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral nerve amyloidosis<br>Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner. | Other: 18-F Florbetapir PET/MR scan<br>* 18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locations of peripheral nerve 18-F Florbetapir uptake | Standardized uptake value (SUV) | 50-120 minutes post injection | 
| Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse) | Heterogeneous vs. Homogeneous, focal vs. diffuse. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate. | 50-120 minutes post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle) | Hypointense, isointense or hyperintense relative to skeletal muscle. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate. | 50-120 minutes post injection | 
| Morphologic changes | Presence or absence of neural enlargement | 50-120 minutes post injection | 
| Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement) | Solid, heterogeneous or peripheral enhancement. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate. | 50-120 minutes post injection | 
| Additional sites of 18-F Florbetapir uptake | i.e. cardiac myocardium, skeletal muscle, bone marrow | 50-120 minutes post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Nerve Amyloidosis