Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging

Multiple Sclerosis Clinical Trial

— SELPET  

Official title:

Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06460077
• Other study ID #: SELPET
• Status: Enrolling by invitation
• Start date: June 2024
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Smoldering inflammation is recognized as a critical contributor to MS progression-related CNS damage. Activated microglia and macrophages particularly at chronic lesion edge are believed to promote lesion growth. Reversing their harmful activity may prove to be an efficient way to halt progression independent of relapses in MS.

These smoldering, or chronic active lesions can be detected in vivo using advanced imaging techniques. 1) Specific algorithms can be used to identify lesion growth, with a hypothesis that the slowly evolving lesions (SEL) are the ones harboring a rim of activated microglial cells, which contribute to damage in the surrounding tissue, and lesion growth. 2) Lesions partially or entirely surrounded by rims of increased tissue intensity on QSM-MRI (quantitative susceptibility mapping) sequences are considered as iron rim lesions, with iron-containing proinflammatory microglia/macrophages at the lesion edge. 3) In addition, TSPO-PET imaging can be used to identify chronic active lesions based on TSPO-expression by activated innate immune cells, and their gathering at the edges of chronic active lesions. The TSPO-PET analysis of chronic active lesions can be semi-automated, and the specific radioligand binding at the chronic active lesion edge can be quantitated, which enhances the sensitivity of this method.

Despite existing preliminary data demonstrating increased QSM signal TSPO-positive lesions, it is yet to be demonstrated how these three imaging methods perform in identifying chronic active lesions when compared to each other at larger scale.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 2028
• Est. primary completion date: June 2028
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
Finland	Turku PET Centre	Turku	Finland Proper

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of three different imaging	The number of lesions identified using each respective method and the potential co-localization of the RIM+ lesions identified using the various methods.	18 months, 36 months
Secondary	Correlation of imaging and clinical variables	Imaging variables from PET and MR imaging correlated with clinical status of the patient evaluated with Expanded Disability Status scale, quality of life questionnaires and neuropsychological evaluation	18 months, 36 months