Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis (TRACK-ALS)

May 19, 2020 updated by: Suma Babu, Massachusetts General Hospital
This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently which may in turn impact the pace for ALS drug discovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this trial, approximately 200 subjects will participate in this study from 2 Northeast ALS Consortium (NEALS) centers in the United States. Fifty (50) ALS participants will be age and gender matched to 50 participants with no known neurological disorder (healthy controls). Of these, twenty five (25) ALS participants will be age (±5 years) gender and binding affinity (TSPO) matched to 25 healthy controls.

During the enrollment period 200 participants will be screened and 100 participants will ultimately be scanned. There will be a maximum allowed time of 45 days between the screening and baseline visits (1st scan). All 100 subjects will undergo MRI scanning and clinical assessment at the Baseline Visit. Healthy control participants will have no further follow-up visits once they have completed their participation in the screening and baseline visits. Only 50 subjects from this sample will undergo PET scanning. The ALS participants will return for follow-up MRI scanning and clinical assessments every three months and follow-up PET scanning every 6 months over a 12-month period.

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 200 subjects will be screened and approximately 100 subjects will be enrolled. Fifty (50) subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS, fifty (50) subjects will have no known neurological disease.

Description

Inclusion Criteria

Study subjects meeting all of the following criteria will be allowed to enroll in the study:

  1. Male or female, aged 18 to 80
  2. Medically safe to undergo MRI scans
  3. Able to safely lie supine for at least 90 minutes in the opinion of the Site Investigator
  4. Capable of providing informed consent and following trial procedures
  5. Geographically accessible to the site

ALS subjects must also meet the following criteria:

  1. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by modified El Escorial criteria
  2. ALS Cognitive Behavioral Screen score >10 on the cognitive scale and/or >32 on the behavioral scale

Those ALS subjects participating in the optional lumbar puncture portion of the study must also meet the following criteria:

1. Subjects medically able to undergo lumbar puncture (LP) as determined by the investigator (i.e., no bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).

For those subjects participating in the PET scan portion of the study, subjects must also meet the following criteria:

  1. Medically safe to undergo PET scans
  2. No prior radiation exposure that exceeds the site's current guidelines
  3. No known allergy to any components of the tracer
  4. Baseline ECG values are within normal range
  5. Subjects must meet main study entry criteria

Exclusion Criteria

Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:

  1. Any contraindication to undergo MRI studies such as

    1. History of a cardiac pacemaker or pacemaker wires
    2. Metallic particles in the body
    3. Vascular clips in the head
    4. Prosthetic heart valves
    5. Claustrophobia
  2. Diagnosis of Parkinson's disease or Alzheimer's disease
  3. Diagnosis of renal failure
  4. Have active or chronic autoimmune disease (such as hepatitis or HIV), infection, or taking immunosuppressive medications such as steroids, cyclophosphamide, etc.
  5. Presence of diaphragm pacing system (DPS)
  6. The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to SI judgment
  7. Pregnant women or women currently breastfeeding
  8. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

In addition, any subject meeting any of the following criteria during screening evaluations will be excluded from entry into the PET portion of the study:

  1. Radiation exposure that exceeds the site's current guidelines
  2. Low affinity TSPO binders determined by having a Thr/Thr polymorphism in the TSPO gene (rs6971) at the Screening Visit

Women of Childbearing Potential (WOCBP) For the purposes of this study, women of child bearing potential are defined as all women who are capable of becoming pregnant, unless they meet one of the following criteria:

  • 12-months post-menopausal
  • Post-hysterectomy
  • Surgically sterile

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amyotrophic Lateral Sclerosis (ALS)
Subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS.
Drug: [18F] GE-180
PET Tracer Ligand
Other Names:
  • ligand
  • PET Tracer
Healthy Controls
Subjects with no known neurological disorder.
Drug: [18F] GE-180
PET Tracer Ligand
Other Names:
  • ligand
  • PET Tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging.
Time Frame: 12 months
Aim 1 will be accomplished by obtaining [18F] GE-180 PET imaging from 25 people with ALS compared to 25 age, gender, and binding affinity matched healthy volunteers.
12 months
Define anatomical, structural, and functional changes in the brain via MRI of ALS Subjects vs. Healthy Controls at Baseline
Time Frame: 12 months
Aim 1 will be accomplished by obtaining state of-the-art MRI acquisition sequences from 50 people with ALS compared to 50 MRI age- and gender-matched healthy volunteers.
12 months
Determine systemic inflammatory factors that may modify the progression or other clinical or imaging correlates of ALS.
Time Frame: 12 months
Blood from 100 subjects will be studied to quantitate circulating pro- and anti-inflammatory monocyte/macrophage and T cells, with results to be correlated with neuroimaging and evaluated as potential biomarkers of disease progression.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression.
Time Frame: 12 months
Clinical and [18F] GE-180 PET imaging data will be collected every 6 months from the 25 people with ALS for at least 12 months.
12 months
Determine the longitudinal changes in the anatomical, structural, and functional measures in people with ALS, and build ALS prediction models using the clinical and MRI data.
Time Frame: 12 months
Clinical and MRI data will be collected every 3 months from 50 people with ALS for at least 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Cedars-Sinai Medical Center
ALS Association
The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Suma Babu, MD, Massachusetts General Hospital
  • Principal Investigator: Joseph Masdeu, MD, PhD, Houston Methodist Neurological Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P000140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis (ALS)

Clinical Trials on [18F] GE-180

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe