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PET Imaging in ALS Patients

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ClinicalTrials.gov Identifier: NCT02236897
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Lyle W. Ostrow, MD, PhD, Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Other: PET Scanning Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers
Study Start Date : August 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PET Scanning
Imaging of mGluR5 using PET scanning
 Other: PET Scanning


Outcome Measures
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Primary Outcome Measures :
  1. Glutamate Receptor Distribution [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236897


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
ALS Association
Investigators
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Principal Investigator: Lyle Ostrow, MD, PhD Johns Hopkins University
More Information
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Responsible Party: Lyle W. Ostrow, MD, PhD, Assistant Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02236897    
Other Study ID Numbers: NA_00073452
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases