A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity,

A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity. Correlation between [11C]-PK-11195 or [18F]-NAF PET (Positron Emission Tomography) and high field MRI (Magnetic Resonance Imaging): a synergistic effect by using a double-technique approach. - A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001202-34-IT

Enrollment

Registered

2021-06-08

Start date

2016-05-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 100000004852

Interventions

Product Name: Na18F Product Code: Na18F Pharmaceutical Form: Solution for injection Current Sponsor code: NaF Concentration unit: Ci/kg curie(s)/kilogram Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Sex: Female and Male - Age: = 18 years old - Diagnosis of Multiple Sclerosis according to McDonald criteria, 2010 rev. - EDSS 0-5.5 - Cerebral MRI with Gadolinium within two weeks the PET scanning - High cortical disease activity (presence of at least 10 cortical lesions and/or epilepsy/seizures not secondary to non-MS pathology) and/or severe mnestic or executive impairment in neuropsychological tests. - informed consent - for [18F]-NaF-PET study, a sub-group of patients who presented seizures in the past 2 months will be chosen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Co-occurring of other illness that can alter PET imaging (neoplasms, infectious disease, etc) - previous brain surgery - pregnancy (for women in reproductive age, a b-HCG test will be performed) or breast feeding - allergy or intolerance to one or more of the drugs employed in this study

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objectives of this study are: - to verify the usefulness of PET imaging in Multiple Sclerosis and to confirm its sensitivity in demonstrating grey matter damage, even improving or integrating MRI imaging, from qualitative (by showing the presence of damaged grey matter, not detected by MRI) and quantitative (by grading the grey matter lesion activity) point of view; - to evaluate the PK11195 or NaF ability to show micro-structural changes within the Normal Appearing Grey Matter, thus improving the spatial and functional resolution of MRI. ;Secondary Objective: - To verify, by using [11C]-PK11195-PET, the degree of microglial activation within cortical lesions and the normal appearing grey matter, aiming at clarifying the origin of cortical damage and at grading those cortical lesions already detected by MRI; - to verify, by using [18F]-NaF-PET, the presence of blood brain barrier damage in cortical lesions, aiming at identifying and differentiate hyper-acute/acute cortical lesions from sub-acute/chronic cortical lesions. ;Primary end point(s): To detect the presence of cortical lesions in PET images at timepoint t=40 minutes for 18F-Na and at timepoint t=20 minutes for PK11195 . To verify if these lesions are also detected by MRI sequences;Timepoint(s) of evaluation of this end point: Primary endpoint detection time approximately overlaps the time of acquisition of the two acquisitions (PET and MRI), imaging fusion and the reading of images. We estimate a period of one month after the acquisition of the last exam.	—

Measure

Time frame

Main Objective: Primary objectives of this study are: - to verify the usefulness of PET imaging in Multiple Sclerosis and to confirm its sensitivity in demonstrating grey matter damage, even improving or integrating MRI imaging, from qualitative (by showing the presence of damaged grey matter, not detected by MRI) and quantitative (by grading the grey matter lesion activity) point of view; - to evaluate the PK11195 or NaF ability to show micro-structural changes within the Normal Appearing Grey Matter, thus improving the spatial and functional resolution of MRI. ;Secondary Objective: - To verify, by using [11C]-PK11195-PET, the degree of microglial activation within cortical lesions and the normal appearing grey matter, aiming at clarifying the origin of cortical damage and at grading those cortical lesions already detected by MRI; - to verify, by using [18F]-NaF-PET, the presence of blood brain barrier damage in cortical lesions, aiming at identifying and differentiate hyper-acute/acute cortical lesions from sub-acute/chronic cortical lesions. ;Primary end point(s): To detect the presence of cortical lesions in PET images at timepoint t=40 minutes for 18F-Na and at timepoint t=20 minutes for PK11195 . To verify if these lesions are also detected by MRI sequences;Timepoint(s) of evaluation of this end point: Primary endpoint detection time approximately overlaps the time of acquisition of the two acquisitions (PET and MRI), imaging fusion and the reading of images. We estimate a period of one month after the acquisition of the last exam.

—

Secondary

Measure	Time frame
Secondary end point(s): 1.To quantify, by using [11C]-PK11195-PET, microglial activation degree within cortical lesions and ¿MRI normal appearing grey matter¿ at t=20 minutes - To estimate the correlation of microglial activation with some demographic and clinical data (age, disease duration, disability, EDSS) 2- To quantify, by using [18F]-NaF-PET, blood brain barrier damage signs in cortical lesions at t=40 minutes - To estimate the correlation of microglial activation with some demographic and clinical data (age, disease duration, disability, EDSS) ;Timepoint(s) of evaluation of this end point: Secondary endpoint detection time approximately overlaps the time of acquisition of the two acquisitions (PET and MRI), imaging fusion and the reading of images. We estimate a period of one month after the acquisition of the last exam.	—

Measure

Time frame

Secondary end point(s): 1.To quantify, by using [11C]-PK11195-PET, microglial activation degree within cortical lesions and ¿MRI normal appearing grey matter¿ at t=20 minutes - To estimate the correlation of microglial activation with some demographic and clinical data (age, disease duration, disability, EDSS) 2- To quantify, by using [18F]-NaF-PET, blood brain barrier damage signs in cortical lesions at t=40 minutes - To estimate the correlation of microglial activation with some demographic and clinical data (age, disease duration, disability, EDSS) ;Timepoint(s) of evaluation of this end point: Secondary endpoint detection time approximately overlaps the time of acquisition of the two acquisitions (PET and MRI), imaging fusion and the reading of images. We estimate a period of one month after the acquisition of the last exam.

—

Countries

Italy

Contacts

Public ContactUOC di Neurologia B

Azienda Ospedaliera Universitaria Integrata Verona- UOC di Neurologia

supporto.noprofit@ospedaleuniverona.it0458124768

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026