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Completed

NCT Number: NCT03019029

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

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.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18-F Florbetapir PET/MR scan

Other

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

Primary outcomes

  1. Locations of peripheral nerve 18-F Florbetapir uptake

    Time frame: 50-120 minutes post injection

    Standardized uptake value (SUV)

  2. 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.

Secondary outcomes

  1. 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.

  2. Morphologic changes

    Time frame: 50-120 minutes post injection

    Presence or absence of neural enlargement

  3. 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.

  4. Additional sites of 18-F Florbetapir uptake

    Time frame: 50-120 minutes post injection

    i.e. cardiac myocardium, skeletal muscle, bone marrow

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2017
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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