Analysis of pathophysiology in multiple sclerosis using new PET tracer

JRCT ID: jRCT1021240027

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Multiple sclerosis
• Date of first enrollment: 30/09/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): PET scanning using [18F]SMBT-1

Outcome(s)

• Primary Outcome: The primary outcome measure involves determining the brain uptake value after [18F]SMBT-1 administration as Standardized Uptake Value (SUV) and SUV ratio (SUVR).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 60age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hiraoka Kotaro
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation,the Ministry of Education, Culture, Sports, Science and Technology