Clinical Trial: Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
Brief Summary: 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 Summary: 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.
Sponsor: Mayo Clinic
Current Primary Outcome:
- Locations of peripheral nerve 18-F Florbetapir uptake [ Time Frame: 50-120 minutes post injection ]Standardized uptake value (SUV)
- Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse) [ Time Frame: 50-120 minutes post injection ]Heterogeneous vs. Homogeneous, focal vs. diffuse. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle) [ Time Frame: 50-120 minutes post injection ]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.
- Morphologic changes [ Time Frame: 50-120 minutes post injection ]Presence or absence of neural enlargement
- Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement) [ Time Frame: 50-120 minutes post injection ]Solid, heterogeneous or peripheral enhancement. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.
- Additional sites of 18-F Florbetapir uptake [ Time Frame: 50-120 minutes post injection ]i.e. cardiac myocardium, skeletal muscle, bone marrow
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: January 3, 2017
Date Started: March 2017
Date Completion: December 2018
Last Updated: February 9, 2017
Last Verified: February 2017