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

Phase 1

Completed

• Conditions: Amyloidosis
• Interventions: Other: 18-F Florbetapir PET/MR scan

• Registration Number: NCT03019029
• Lead Sponsor: Mayo Clinic

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 Description

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.

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Study Start: 2017-03-13
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral nerve amyloidosis	18-F Florbetapir PET/MR scan	Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.

Primary Outcome Measures

Name	Time	Method
Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse)	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.
Locations of peripheral nerve 18-F Florbetapir uptake	50-120 minutes post injection	Standardized uptake value (SUV)

Secondary Outcome Measures

Name	Time	Method
Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement)	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.
Morphologic changes	50-120 minutes post injection	Presence or absence of neural enlargement
Additional sites of 18-F Florbetapir uptake	50-120 minutes post injection	i.e. cardiac myocardium, skeletal muscle, bone marrow
T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle)	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States