[18F]F-DED PET Imaging of Reactive Astrocytes in Multiple Sclerosis (F-DED PET MS)

September 1, 2026 updated by: Parc de Salut Mar

[18F] Fluorodeprenyl-D2 PET Imaging of Reactive Astrocytes as Chronic Active Inflammation Marker in Multiple Sclerosis

Despite significant advancements in multiple sclerosis (MS) treatment over the past decade, a specific imaging biomarker for predicting disease progression remains lacking. This project is conducted as a non-therapeutic clinical trial with an investigational medicinal product and aims to validate PET imaging with the radiotracer [18F]fluorodeprenyl-D2 ([18F]F-DED) as a diagnostic tool for detecting chronic active lesions in MS and to evaluate its potential as a predictor of disease progression. Chronic astrocyte activation plays a key role in MS pathology, yet current imaging techniques, such as MRI, have limited sensitivity in identifying chronic neuroinflammation. By leveraging PET imaging with [18F]F-DED, which specifically targets activated astrocytes, this study seeks to provide a more precise assessment of chronic inflammatory lesions in MS patients. The project will follow a cross-sectional and longitudinal design: O1) To validate the ability of [18F]F-DED PET to identify chronic active lesions by comparing PET findings with MRI markers, including paramagnetic rings (PRLs) and determine its diagnostic accuracy; O2) To explore the relationship between astrocyte-targeted PET imaging and blood-based biomarkers of astrogliosis ; O3) To assess the predictive value of PET-detected chronic inflammation in disease progression over a three-year follow-up period through regression analysis, integrating clinical parameters such as disability progression (EDSS scores), relapse rates, and MRI changes. A total of 30 MS patients will be recruited from the MS Unit of Hospital del Mar and undergo PET and MRI imaging, following a single intravenous administration of the investigational radiotracer [18F]F-DED, together with MRI imaging with advanced image fusion techniques ensuring precise lesion localization. Machine learning models will be applied to imaging and clinical data to identify biomarkers associated with MS progression. By improving diagnostic accuracy and predicting disease evolution, this clinical trial aims to enhance patient stratification and treatment personalization.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar Research Institute
        • Contact:
        • Contact:
          • Silvia Susin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-65 years.
  • Confirmed diagnosis of multiple sclerosis according to the 2017 McDonald criteria.
  • Ability to undergo MRI and PET imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]F-DED PET
Participants with multiple sclerosis will receive a single intravenous administration of [18F]fluorodeprenyl-D2 ([18F]F-DED; 200 ± 25 MBq) followed by PET/CT imaging. MRI will be performed within one week of the PET/CT scan. Participants will undergo longitudinal clinical follow-up for 3 years.
Drug: [18F]fluorodeprenyl-D2
Participants will receive a single intravenous administration of [18F]fluorodeprenyl-D2 ([18F]F-DED) at a dose of 200 ± 25 MBq, followed by PET/CT imaging to assess reactive astrocytes in multiple sclerosis lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of [18F]F-DED PET for Detecting Chronic Active Lesions
Time Frame: Baseline (PET/CT and MRI performed within 1 week)
Diagnostic accuracy of [18F]F-DED PET imaging for identifying chronic active lesions in patients with multiple sclerosis, using MRI-detected paramagnetic rim lesions (PRLs) as the reference standard. Diagnostic performance will be assessed by area under the receiver operating characteristic curve (AUC-ROC), sensitivity, and specificity.
Baseline (PET/CT and MRI performed within 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

September 1, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/12341/I
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2026-525702-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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