RECRUITING

Multicenter ALS Imaging Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-site study of ALS participants and healthy controls who will undergo brain and cervical spine MRIs and NfL blood testing at up-to 4 time points over the course of a year. The primary goal is to identify objective biomarkers of disease progression that are biologically relevant, linearly progressive, and sensitive to change.

Official Title

Multicenter Longitudinal Imaging in ALS for Disease Biomarker Development

Quick Facts

Study Start:2024-09-15
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06735014

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \< 24 months since onset of symptoms
  2. * Definite, probable, laboratory-supported probable, or possible ALS by El Escorial criteria OR definite, probable, or possible ALS by Awaji-Shima Criteria
  3. * Forced vital capacity within the last 90 days ≥ 60% of the predicted value
  4. * Able to consent for themselves
  5. * Able to read and speak English
  6. * Clear of any contraindications for MRI
  1. * Individuals will be excluded if they have any condition that makes MRI unsafe or if they are unable to comply with instructions.
  2. * All participants will undergo a neurologic examination at enrollment. Control participants with clinically significant abnormal findings on neurological examination will be excluded from the study.

Contacts and Locations

Study Contact

Melisa Bailey, MS
CONTACT
612-624-4911
baile807@umn.edu

Principal Investigator

Pramod Pisharady, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32608
United States
Northwestern University
Evanston, Illinois, 60208
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Pramod Pisharady, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Registration Dates

Study Start Date2024-09-15
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-09-15
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • Magnetic Resonance Imaging
  • MRI
  • ALSFRS-R
  • ECAS
  • plasma neurofilament light
  • NfL

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis
  • ALS