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