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

Primary Purpose

Amyloidosis

Status

Enrolling by invitation

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

18-F Florbetapir PET/MR scan

About this trial

This is an interventional diagnostic trial for Amyloidosis focused on measuring Peripheral Nerve Amyloidosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peripheral nerve amyloidosis

Arm Description

Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.

Outcomes

Primary Outcome Measures

Locations of peripheral nerve 18-F Florbetapir uptake

Standardized uptake value (SUV)

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.

Secondary Outcome Measures

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.

Morphologic changes

Presence or absence of neural enlargement

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.

Additional sites of 18-F Florbetapir uptake

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

Full Information

NCT ID

NCT03019029

First Posted

January 3, 2017

Last Updated

January 16, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03019029

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 13, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyloidosis

Keywords

Peripheral Nerve Amyloidosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peripheral nerve amyloidosis

Arm Type

Experimental

Arm Description

Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.

Intervention Type

Other

Intervention Name(s)

18-F Florbetapir PET/MR scan

Intervention Description

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

Primary Outcome Measure Information:

Title

Locations of peripheral nerve 18-F Florbetapir uptake

Description

Standardized uptake value (SUV)

Time Frame

50-120 minutes post injection

Title

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

Description

Heterogeneous vs. Homogeneous, focal vs. diffuse. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.

Time Frame

50-120 minutes post injection

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

50-120 minutes post injection

Title

Morphologic changes

Description

Presence or absence of neural enlargement

Time Frame

50-120 minutes post injection

Title

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

Description

Solid, heterogeneous or peripheral enhancement. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.

Time Frame

50-120 minutes post injection

Title

Additional sites of 18-F Florbetapir uptake

Description

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

Time Frame

50-120 minutes post injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen M Broski

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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