An interventional study of [18F]fluorodeprenyl-D2 in Multiple Sclerosis, sponsored by Parc de Salut Mar. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Diagnostic
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
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.
Time frame: Baseline (PET/CT and MRI performed within 1 week)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 36 months is above that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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