PET Imaging in ALS Patients

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Other: PET Scanning

• Registration Number: NCT02236897
• Lead Sponsor: Johns Hopkins University

Brief Summary

This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-11
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Male or female ALS patients, ranging in age from 18-80.
• Must meet El Escorial Criteria for Probable or Definite ALS.
• Disease duration >1 year, but <3 years.
• Weakness in at least two extremities.
• Forced vital capacity less than 80% and greater than 50%.

Exclusion Criteria

• Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes.
• Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an MRI scan.
• Absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists.
• Significant abnormalities of hepatic or renal function, or illicit substance use.
• Positive drug screen. (Subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. Medication history will be obtained during screening).
• Weighs > 350 lbs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET Scanning	PET Scanning	Imaging of mGluR5 using PET scanning

Primary Outcome Measures

Name	Time	Method
Glutamate Receptor Distribution	1 year	The two primary outcome variables (VT and BPND) are quantitative estimates of mGluR5 distribution in the defined central nervous system regions. We will employ plasma reference graphical analysis (PRGA) which yielded the most accurate estimates of BPND and VT in a test-retest scheme. We will perform various analyses to determine if BPND or VT measurements in the volumes of interest differ between the ALS and control subject groups.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States