Status:
COMPLETED
PET Imaging in ALS Patients
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
ALS Association
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18-80 years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02236897
Start Date
August 1 2013
End Date
March 1 2017
Last Update
March 7 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287