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NCT03019029 Clinical Trial

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

Amyloidosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03019029
Other study ID # 16-006798
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 13, 2017
Est. completion date March 22, 2022

Study information
Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date March 22, 2022
Est. primary completion date March 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Locations of peripheral nerve 18-F Florbetapir uptake Standardized uptake value (SUV) 50-120 minutes post injection
Primary 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 T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle) 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
Secondary Morphologic changes Presence or absence of neural enlargement 50-120 minutes post injection
Secondary Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement) 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
Secondary Additional sites of 18-F Florbetapir uptake i.e. cardiac myocardium, skeletal muscle, bone marrow 50-120 minutes post injection
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