Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging

NCT06460077 | Enrolling By Invitation

• 1 other identifier: SELPET
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in Multiple Sclerosis (MS) in vivo.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of lesions

  The number of lesions identified using each respective method

  18 months, 36 months

• Co-localization of lesions

  Potential co-localization of the RIM+ lesions identified using the various methods.

  18 months, 36 months

Secondary Outcomes (4)

• Correlation of PET imaging and clinical variables

  18 months, 36 months

• Correlation of magnetic resonance imaging and clinical variables

  18 months, 36 months

• Correlation of quality of life questionnaires and clinical variables

  18 months, 36 months

• Correlation of neuropsychological evaluation and clinical variables

  18 months, 36 months

Study Arms (1)

Patients with Multiple Sclerosis

Patients who have previously participated in PET-imaging studies and from whom slowly expanding lesions as well as TSPO-rim-positive lesions and iron rims at the edge of lesions are found

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

52 MS patients with simultaneous QSM-MRI and TSPO-PET and with available longitudinal brain MRI images (minimum 1 year) have been identified. With an average detection frequency of \>= 1 SEL in 70% of MS patients, there will be sufficient imaging material for successful conduct of the study.

You may qualify if:

• Signing the informed consent form
• MS diagnosis in accordance with McDonald 2017 criteria
• Available longitudinal brain MR images (minimum 1 year)
• Simultaneous QSM MRI sequence and TSPO-PET
• Lesions with iron rim/s

You may not qualify if:

• Patients with other neurodegenerative disease than MS
• Patients with other autoimmune disease than MS
• Patients with other significant or malignant underlying disease of any other organ system
• Patients that are pregnant or breast-feeding
• Corticosteroid treatment within 4 weeks of imaging
• Patients with significant abnormal findings other than MS in the screening MRI
• Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
• Contraindication to PET scan investigations
• Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study
• Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Airas, MD,Professor

  Turku University Hospital, division of clinical neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

FI (1)