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
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis (ALS)||Other: PET Scanning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: PET Scanning
Imaging of mGluR5 using PET scanning
Other: PET Scanning
- 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.
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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|
- 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%.
- 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.
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
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Lyle Ostrow, MD, PhD||Johns Hopkins University|
|Responsible Party:||Lyle W. Ostrow, MD, PhD, Assistant Professor of Neurology, Johns Hopkins University|
|Other Study ID Numbers:||
|First Posted:||September 11, 2014 Key Record Dates|
|Last Update Posted:||March 7, 2017|
|Last Verified:||March 2017|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases