Amyotrophic Lateral Sclerosis (ALS)TRACK-ALSNCT02559869
Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- [18F] GE-180
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to 28 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Study subjects meeting all of the following criteria will be allowed to enroll in the study:
- Male or female, aged 18 to 80
- Medically safe to undergo MRI scans
- Able to safely lie supine for at least 90 minutes in the opinion of the Site Investigator
- Capable of providing informed consent and following trial procedures
- Geographically accessible to the site
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- ALS subjects must also meet the following criteria:
- Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by modified El Escorial criteria
- 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:
- Medically safe to undergo PET scans
- No prior radiation exposure that exceeds the site's current guidelines
- No known allergy to any components of the tracer
- Baseline ECG values are within normal range
- Subjects must meet main study entry criteria
Who cannot join
- Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:
- Any contraindication to undergo MRI studies such as
- History of a cardiac pacemaker or pacemaker wires
- Metallic particles in the body
- Vascular clips in the head
- Prosthetic heart valves
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- Claustrophobia
- Diagnosis of Parkinson's disease or Alzheimer's disease
- Diagnosis of renal failure
- Have active or chronic autoimmune disease (such as hepatitis or HIV), infection, or taking immunosuppressive medications such as steroids, cyclophosphamide, etc.
- Presence of diaphragm pacing system (DPS)
- 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
- Pregnant women or women currently breastfeeding
- 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:
- Radiation exposure that exceeds the site's current guidelines
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Houston Methodist Hospital
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- [18F] GE-180
- Keywords
- Biofluid, ALS, MRI, PET, Imaging, Biomarkers, Amyotrophic Lateral Sclerosis, TRACK ALS, pathology
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] GE-180Drug
Also called ligand, PET Tracer
PET Tracer Ligand
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic Lateral Sclerosis (ALS) | Subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS. Receives: Drug: [18F] GE-180 | |
| Healthy Controls | Subjects with no known neurological disorder. Receives: Drug: [18F] GE-180 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging.
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.
Measured: 12 months
Define anatomical, structural, and functional changes in the brain via MRI of ALS Subjects vs. Healthy Controls at Baseline
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.
Measured: 12 months
Determine systemic inflammatory factors that may modify the progression or other clinical or imaging correlates of ALS.
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.
Measured: 12 months
Secondary outcomes (2)
Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression.
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.
Measured: 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.
Clinical and MRI data will be collected every 3 months from 50 people with ALS for at least 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Cedars-Sinai Medical Center, ALS Association
- Responsible party
- Principal investigator, Suma Babu, Massachusetts General Hospital
- Investigators
- Suma Babu, MD, Principal investigator, Massachusetts General HospitalJoseph Masdeu, MD, PhD, Principal investigator, Houston Methodist Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559869
- Sponsor's protocol ID
- 2015P000140
- Acronym
- TRACK-ALS
- Status last verified
- May 2020
- First submitted
- 23 Sep 2015
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02559869
- Acronym / sponsor ID
- TRACK-ALS / 2015P000140
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Biofluid, ALS, MRI, PET, Imaging, Biomarkers, Amyotrophic Lateral Sclerosis, TRACK ALS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Cedars-Sinai Medical Center, ALS Association
- Study start
- Nov 2015
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic Lateral Sclerosis (ALS) | – | Drug: [18F] GE-180Subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS. |
| Healthy Controls | – | Drug: [18F] GE-180Subjects with no known neurological disorder. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- Study subjects meeting all of the following criteria will be allowed to enroll in the study:
- Male or female, aged 18 to 80
- Medically safe to undergo MRI scans
- Able to safely lie supine for at least 90 minutes in the opinion of the Site Investigator
- Capable of providing informed consent and following trial procedures
Key exclusion criteria (21 listed)
- Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:
- Any contraindication to undergo MRI studies such as
- Diagnosis of Parkinson's disease or Alzheimer's disease
- Diagnosis of renal failure
- Have active or chronic autoimmune disease (such as hepatitis or HIV), infection, or taking immunosuppressive medications such as steroids, cyclophosphamide, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F] GE-180Also: ligand, PET TracerPET Tracer Ligand | Drug | Amyotrophic Lateral Sclerosis (ALS), Healthy Controls |
Primary outcome
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.
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.
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.
2 secondary outcomes
Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- NEALS website (Northeast ALS Consortium)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suma Babu, MD principal investigator
Massachusetts General Hospital
Joseph Masdeu, MD, PhD principal investigator
Houston Methodist Neurological Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.