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

NCT03019029 | Completed Phase 1

• 1 other identifier: 16-006798
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Keywords

Peripheral Nerve Amyloidosis

Outcome Measures

Primary Outcomes (2)

• Locations of peripheral nerve 18-F Florbetapir uptake

  Standardized uptake value (SUV)

  50-120 minutes post injection

• Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse)

  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 Outcomes (4)

• T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle)

  50-120 minutes post injection

• Morphologic changes

  50-120 minutes post injection

• Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement)

  50-120 minutes post injection

• Additional sites of 18-F Florbetapir uptake

  50-120 minutes post injection

Study Arms (1)

Peripheral nerve amyloidosis

EXPERIMENTAL

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

Interventions

18-F Florbetapir PET/MR scan OTHER

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

Peripheral nerve amyloidosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults: 18-100
• Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy

You may not qualify if:

• Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.)
• Claustrophobia
• BMI over 38

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen M. Broski, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 12, 2017
• Study Start: March 13, 2017
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)