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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral nerve amyloidosis | Experimental | Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18-F Florbetapir PET/MR scan | Other | 18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M. Broski, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan
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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 |