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Radioactive Tracer for Multiple Sclerosis
Phase 1
Recruiting
Led By Daniel S Reich, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after first pet/ct scan
Awards & highlights
Study Summary
This trial tests whether a radioactive tracer (minibody) can help identify certain immune cells in people w/ MS & PML. Eligible participants aged 18+ must come to clinic for 3 visits over 4-6 weeks for physical & neurological exams, MRI, & PET scan.
Who is the study for?
Adults aged 18+ with Multiple Sclerosis or Progressive Multifocal Leukoencephalopathy can join. They must be part of existing NINDS studies, understand and agree to the study's consent form, follow all procedures, and women must use effective contraception. Excluded are pregnant or breastfeeding individuals, those who can't have MRI contrast or fit in scanners, and anyone with conditions that could affect their participation.Check my eligibility
What is being tested?
The trial is testing a radioactive tracer called minibody (89 Zr-Df-crefmirlimab) used during PET scans to detect immune cells in the CNS of MS and PML patients. Participants will receive an infusion of minibody followed by PET scans over several visits spanning 4-6 weeks.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include reactions related to the infusion process such as discomfort at injection site or allergic reactions, plus any risks associated with exposure to radiation from the tracer used in PET scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after first pet/ct scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after first pet/ct scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Infiltration of CD8+ T cells in the CNS of adults with MS and PML via PET-CT scans using a minibody with high affinity for CD8+ T cells.
Secondary outcome measures
For the PML cohort with longitudinal evaluation, effects of immune reconstitution, either spontaneous or facilitated, on 89Zr-Dfcrefmirlimab uptake.
Safety of 89Zr-Dfcrefmirlimab in the participants with CNS disease.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Progressive Multifocal LeukoencephalopathyExperimental Treatment1 Intervention
PML cohort- Up to five study visits. (1) Baseline; (2) Day 0: MRI brain (with gadolinium) followed by an intravenous injection of anti-CD8 minibody (aka "PET/CT tracer"); (3) Day 1: PET/CT scan; (4) Study visit 4 (optional; time-period between study visit 3 and 4 is variable): MRI brain (with gadolinium) followed by an intravenous injection of anti-CD8 minibody (aka "PET/CT tracer") following clinical, radiological and/or laboratory-defined immune reconstitution (spontaneous or facilitated); (5) Study visit 5: PET/ CT scan
Group II: Multiple SclerosisExperimental Treatment1 Intervention
MS cohort- Three study visits. (1) Baseline; (2) Day 0: MRI brain/spinal cord (with gadolinium) followed by an intravenous injection of anti-CD8 minibody (aka"PET/CT tracer"); (3) Day 1: PET/CT scan
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,341 Previous Clinical Trials
649,579 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
9,299 Patients Enrolled for Multiple Sclerosis
Daniel S Reich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
10 Previous Clinical Trials
4,322 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,322 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PML or PML-IRIS based on clinical and lab tests.I am 18 years or older with Multiple Sclerosis.I have been diagnosed with Multiple Sclerosis according to the latest criteria.I agree to use effective birth control starting one month before and during the study.I have severe claustrophobia that doesn't improve with anxiety medication.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Multiple Sclerosis
- Group 2: Progressive Multifocal Leukoencephalopathy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree could Multiple Sclerosis be detrimental to individuals?
"Due to a lack of data regarding Multiple sclerosis safety and efficacy, our team has estimated it's risk-level at 1."
Answered by AI
Can adults aged twenty and above participate in this clinical investigation?
"As outlined in the eligibility requirements, this clinical trial is open to participants aged 18 years or older, up to a maximum of 120."
Answered by AI
Could I potentially become a participant in this research program?
"This medical trial seeks patients with multiple sclerosis, between 18 and 120 years of age. Currently, the study is accepting up to 10 candidates for enrolment."
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Is there still opportunity to join this trial as a participant?
"According to clinicaltrials.gov, this experiment is no longer accepting new patients. It was initially announced on May 14th 2023 and last updated on May 8th of the same year. Though this research programme has finished enrolling participants, there are 549 other medical trials that still need volunteers."
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