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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03019029
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 80.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amyloidosis	Other: 18-F Florbetapir PET/MR scan	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scanParticipants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
• Actual Study Start Date: Mar 13, 2017
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Locations of peripheral nerve 18-F Florbetapir uptake [50-120 minutes post injection]

   Standardized uptake value (SUV)

2. 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 Outcome Measures

1. 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.

2. Morphologic changes [50-120 minutes post injection]

   Presence or absence of neural enlargement

3. 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.

4. Additional sites of 18-F Florbetapir uptake [50-120 minutes post injection]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Stephen M Broski, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Stephen M. Broski, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03019029
• Other Study ID Numbers: 16-006798
• First Posted: Jan 12, 2017
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Stephen M. Broski, Principal Investigator, Mayo Clinic: Peripheral Nerve Amyloidosis
• Additional relevant MeSH terms: Amyloidosis

Study Results

No Results Posted as of Jan 18, 2022