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

NCT ID: NCT03019029

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2022-03-22

Brief Summary

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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

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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.

Conditions

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Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

18-F Florbetapir PET/MR scan

Intervention Type OTHER

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

Interventions

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18-F Florbetapir PET/MR scan

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Stephen M. Broski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen M. Broski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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16-006798

Identifier Type: -

Identifier Source: org_study_id

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