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[F-18]SDM-8 for Multiple Sclerosis

Phase < 1
Waitlist Available
Led By Tarun Singhal, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

Novel Assessment of Synaptic Density in Progressive MS

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tissue volume of Distribution (Vt)
Secondary outcome measures
Standardized uptake values (SUV)

Trial Design

1Treatment groups
Experimental Treatment
Group I: [F-18]SDM-8 tracerExperimental Treatment1 Intervention
Subjects will be administered standardized questionnaires for cognitive testing/other co-morbidities. They will undergo PET Scan and 3T Brain MRI. For PET Scan, an intra-arterial catheter will be inserted into the radial artery for [F-18]SDM-8 metabolite blood sampling by a trained anesthesiologist. Allen's test will be performed prior to insertion of the intra-arterial catheter. If arterial line can't be established to obtain metabolite samples, a venous line will be placed. In addition, an intravenous (IV) catheter will be inserted into the radial antecubital or other arm or hand vein for injection of tracer. Radiopharmaceutical will be injected as a bolus (approximately 5mCi for [F-18]SDM-8 followed by 5 mL of saline). The PET session will last up to 120 min. A head support apparatus will be used to minimize head motion. Brain PET data acquisition will begin at the moment of radiotracer injection. For MRI, several pulse sequences will be performed, no IV contrast will be used.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,470,297 Total Patients Enrolled
14 Trials studying Multiple Sclerosis
6,736 Patients Enrolled for Multiple Sclerosis
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,325 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
1,939 Patients Enrolled for Multiple Sclerosis
Tarun Singhal, MDPrincipal InvestigatorBrigham and Women's Hospital
5 Previous Clinical Trials
156 Total Patients Enrolled
4 Trials studying Multiple Sclerosis
137 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Novel Assessment of Synaptic Density in Progressive MS
TARUN SINGHAL 2021. "Novel Assessment of Synaptic Density in Progressive MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634994.
~8 spots leftby Apr 2025
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