PET Imaging in ALS Patients
Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 8, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 7, 2017
March 1, 2017
3.6 years
September 8, 2014
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (1)
PET Scanning
EXPERIMENTALImaging of mGluR5 using PET scanning
Interventions
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- ALS Associationcollaborator
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lyle Ostrow, MD, PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
September 8, 2014
First Posted
September 11, 2014
Study Start
August 1, 2013
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 7, 2017
Record last verified: 2017-03