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

March 12, 2026 updated by: Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral nerve amyloidosis
Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.
Other: 18-F Florbetapir PET/MR scan
18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Stephen M. Broski, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

March 24, 2022

Study Completion (Actual)

March 24, 2022

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimated)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-006798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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