Analysis of pathophysiology in multiple sclerosis using new PET tracer

Not yet recruiting

• Conditions: Multiple sclerosis

• Registration Number: jRCT1021240027

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Multiple Sclerosis Group:

1. Patients who visited the Department of Neurology at Tohoku University Hospital or Tohoku Medical and Pharmaceutical University Hospital after January 1, 2011.
2. Age 18 or older but younger than 60 at the time of analysis.
3. Gender unspecified.
4. Meeting the McDonald Diagnostic Criteria 2017 (24).
5. Individuals judged capable of tolerating approximately 45 minutes of supine PET measurement.

Control Group:

1. Individuals who provided written consent for participation in the study (primarily Japanese native speakers).
2. Generally, individuals of both genders aged 18 or older but younger than 60 at the time of consent.
3. Having a MMSE score of 24 or above.
4. Individuals whom the attending physician judged capable of tolerating approximately 45 minutes of supine PET measurement.

Exclusion Criteria

Multiple Sclerosis Group:

1. Individuals with a current or past medical history of other neurological disorders, substance dependence, or alcohol dependence.
2. Individuals concurrently using irreversible MAO-B inhibitors (selegiline, rasagiline) and reversible MAO-B inhibitors.
3. Habitual smokers (including those who smoked within the past year).
4. Pregnant, breastfeeding, or within 28 days postpartum.
5. Individuals with a history of severe drug allergies or food allergies.
6. Patients with comorbid psychiatric disorders deemed unable to participate in the study.
7. Individuals meeting conditions contraindicating MRI examination (e.g., those with pacemakers, internal metal objects).
8. Individuals with poorly controlled comorbidities and clinically problematic health conditions (e.g., diabetes, hypertension, thyroid/endocrine disorders, congestive heart failure, angina, renal dysfunction with dialysis or estimated Ccr less than 30 mL/min), with the attending physician determining a significant medical risk for participation in the study.
9. Individuals diagnosed with and treated for malignant tumors within the past year.
10. Individuals experiencing a relapse within the past 3 months.
11. Individuals deemed inappropriate for inclusion in the study by the principal investigator.

Control Group:

1. Individuals with a current or past medical history of any neurological disorder.
2. Individuals with a history of substance dependence, alcohol dependence, or similar conditions.
3. Habitual smokers (including those who smoked within the past year).
4. Pregnant, breastfeeding, or within 28 days postpartum.
5. Individuals with a history of severe drug allergies or food allergies.
6. Patients with comorbid psychiatric disorders deemed unable to participate in the study.
7. Individuals meeting conditions contraindicating MRI examination (e.g., those with pacemakers, internal metal objects.
8. Individuals with poorly controlled comorbidities and clinically problematic health conditions (e.g., diabetes, hypertension, thyroid/endocrine disorders, congestive heart failure, angina, renal dysfunction with dialysis or estimated Ccr less than 30 mL/min), with the attending physician determining a significant medical risk for participation in the study.
9. Individuals diagnosed with and treated for malignant tumors within the past year.
10. Individuals deemed inappropriate for inclusion in the study by the principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Standardized Uptake Value (SUV)		The brain uptake value after [18F]SMBT-1 administration as Standardized Uptake Value (SUV)
SUV ratio (SUVR)		The brain uptake value after [18F]SMBT-1 administration as SUV ratio (SUVR)