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PET Imaging in ALS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 8, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date March 7, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Imaging in ALS Patients
Official Title  ICMJE Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE Other: PET Scanning
Study Arms  ICMJE Experimental: PET Scanning
Imaging of mGluR5 using PET scanning
Intervention: Other: PET Scanning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2017)
36
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
38
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02236897
Other Study ID Numbers  ICMJE NA_00073452
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lyle W. Ostrow, MD, PhD, Johns Hopkins University
Original Responsible Party Dr. Jeffrey Rothstein, Johns Hopkins University, Professor of Professor of Neurology and Neuroscience
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ALS Association
Investigators  ICMJE
Principal Investigator: Lyle Ostrow, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP