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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

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after first pet/ct scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after first pet/ct scan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,362 Previous Clinical Trials
650,740 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
9,300 Patients Enrolled for Multiple Sclerosis
Daniel S Reich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
10 Previous Clinical Trials
4,323 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,323 Patients Enrolled for Multiple Sclerosis

Media Library

Progressive Multifocal Leukoencephalopathy Clinical Trial Eligibility Overview. Trial Name: NCT05849467 — Phase 1
Multiple Sclerosis Research Study Groups: Progressive Multifocal Leukoencephalopathy, Multiple Sclerosis
Multiple Sclerosis Clinical Trial 2023: Progressive Multifocal Leukoencephalopathy Highlights & Side Effects. Trial Name: NCT05849467 — Phase 1
Progressive Multifocal Leukoencephalopathy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849467 — Phase 1
~4 spots leftby Jun 2025
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