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

NCT07805473 | Not Yet Recruiting

• 3 other identifiers: 2025/12341/I2026-525702-35-002025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of [18F]F-DED PET for Detecting Chronic Active Lesions

  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)

Study Arms (1)

[18F]F-DED PET

EXPERIMENTAL

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

Interventions

[18F]fluorodeprenyl-D2 DRUG

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.

[18F]F-DED PET

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar Research Institute

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

fluorodeprenyl

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aida Giraldo, MD

CONTACT

933160675; agiraldo@researchmar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09

Locations

ES (1)