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PET Imaging in ALS Patients

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Johns Hopkins University

Status

Completed

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Treatments

Other: PET Scanning

Study type

Interventional

Funder types

Other

Identifiers

NCT02236897
NA_00073452

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

PET Scanning
Experimental group
Description:
Imaging of mGluR5 using PET scanning
Treatment:
Other: PET Scanning

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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