Back to resultsPET Imaging in ALS Patients
Primary Purpose
Amyotrophic Lateral Sclerosis (ALS)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET Scanning
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis (ALS)
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET Scanning
Arm Description
Imaging of mGluR5 using PET scanning
Outcomes
Primary Outcome Measures
Glutamate Receptor Distribution
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02236897
First Posted
September 8, 2014
Last Updated
March 6, 2017
Sponsor
Johns Hopkins University
Collaborators
ALS Association
1. Study Identification
Unique Protocol Identification Number
NCT02236897
Brief Title
PET Imaging in ALS Patients
Official Title
Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
ALS Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET Scanning
Arm Type
Experimental
Arm Description
Imaging of mGluR5 using PET scanning
Intervention Type
Other
Intervention Name(s)
PET Scanning
Primary Outcome Measure Information:
Title
Glutamate Receptor Distribution
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyle Ostrow, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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PET Imaging in ALS Patients
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