Multiple SclerosisF-DED PET MSNCT07805473
[18F]F-DED PET Imaging of Reactive Astrocytes in Multiple Sclerosis
A study testing [18F]fluorodeprenyl-D2 in people with Multiple Sclerosis, run by Parc de Salut Mar at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- [18F]fluorodeprenyl-D2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Confirmed diagnosis of multiple sclerosis according to the 2017 McDonald criteria.
- Ability to undergo MRI and PET imaging.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital del Mar Research Institute
Barcelona, 08003
Silvia Susin, MD, 933160675, ssusin@researchmar.net
Silvia Susin
About this study
Official title: [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.
- Conditions
- Multiple Sclerosis
- Being tested
- [18F]fluorodeprenyl-D2
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]fluorodeprenyl-D2Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [18F]fluorodeprenyl-D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (PET/CT and MRI performed within 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805473
- Sponsor's protocol ID
- 2025/12341/I
- Other IDs
- 2026-525702-35-00, 2025
- Acronym
- F-DED PET MS
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F] Fluorodeprenyl-D2 PET Imaging of Reactive Astrocytes as Chronic Active Inflammation Marker in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07805473
- Acronym / sponsor ID
- F-DED PET MS / 2025/12341/I
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]F-DED PET | Experimental | Drug: [18F]fluorodeprenyl-D2Participants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Confirmed diagnosis of multiple sclerosis according to the 2017 McDonald criteria.
- Ability to undergo MRI and PET imaging.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]fluorodeprenyl-D2Participants 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. | Drug | [18F]F-DED PET |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]fluorodeprenyl-D2 in people with Multiple Sclerosis, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aida Giraldo, MD (933160675, agiraldo@researchmar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of [18F]F-DED PET for Detecting Chronic Active Lesions (time frame: Baseline (PET/CT and MRI performed within 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.