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Demyelination and Remyelination in Multiple Sclerosis (MS) Detected by Brain Amyloid PET-CT

NCT05783934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-30

No results posted yet for this study

Summary

The goal of this clinical trial study is to evaluate the presence of relationships between PET and MRI images indicative of chronic inflammatory activity (smoldering plaques), apparent absence of inflammatory activity (silent plaques without microglial rim), or indicative of more recent inflammatory activity, in contrast-enhanced areas or in T2/Flair-positive areas of not distant onset in patients diagnosed with progressive (secondary or primary) stage multiple sclerosis and in patients in relapse and remission.

Laboratory analysis of serum markers will be performed: neuronal and glial cytoskeletal proteins (e.g., Nf-L, pN-FH, GFAP), and the levels of neurotrophic factors (e.g., BDNF, GDNF) and cytokines (e.g., TNFα, IL-6, IL-1β, interferon) will be evaluated.

Conditions

Interventions

DIAGNOSTIC_TEST

18F-florbetaben PET/CT

The PET/CT study will be performed using a dual time acquisition protocol consisting of an early acquisition and a late acquisition. Early acquisition Early acquisition starts with the patient already positioned on the PET/CT bed and venous access available. A low-dose CT scan is performed for attenuation correction, the PET acquisition is started in list mode and a couple of seconds after the start, 300 MBq of 18F-Florbetaben is administered followed by washing with 10 ml of saline. Early acquisition will last 30 minutes. Late acquisition A low-dose CT scan is performed to correct for attenuation and anatomical localisation, followed by a 20-minute list mode PET acquisition so that images are acquired after 90 minutes (tolerance: +10 minutes) of radiopharmaceutical uptake.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Principal Investigators

  • Giuseppe Trifirò, MD · ICS Maugeri Spa SB IRCCS

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-11-15
Completion
2024-01-09

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783934 on ClinicalTrials.gov