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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03019029

Enrollment

Registered

2017-01-12

Start date

2017-03-13

Completion date

2022-03-24

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis

Keywords

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 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.

Interventions

OTHER18-F Florbetapir PET/MR scan

18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Locations of peripheral nerve 18-F Florbetapir uptake	50-120 minutes post injection	Standardized uptake value (SUV)
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.

Secondary

Measure	Time frame	Description
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.
Morphologic changes	50-120 minutes post injection	Presence or absence of neural enlargement
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.
Additional sites of 18-F Florbetapir uptake	50-120 minutes post injection	i.e. cardiac myocardium, skeletal muscle, bone marrow

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStephen M. Broski, M.D.

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026