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Multiple Sclerosis, Relapsing-RemittingINFLASEPNCT02305264

Imaging of Intracerebral Inflammation in MS

A study testing 18F-DPA-714 and 18F-FDG in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral benzodiazepine receptor (PBR), a target mainly expressed by… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
18F-DPA-714 and 18F-FDG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
2 sitesFrance
Study dates
19 Mar 2012to 10 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers (group I, n=20)
  • Aged 18-65 years;
  • Able to understand the objectives and procedures of the study, and who give inform consent.
  • Patients with relapsing-remitting MS (group II, n=15)
  • Aged 18-65 years
  • Clinically definite MS according to McDonald revised criteria
Show all 17Show fewer
  • Less than 10 year of evolution
  • No clinical relapse during the past 3 months
  • Able to understand the objectives and procedures of the study, and who give inform consent
  • Patients with progressive MS (group III and IV, n=15 per group)
  • Aged 18-65 years
  • Clinically definite MS according to McDonald revised criteria
  • SPMS evolving since more than 10 years for group III (n = 15).
  • PPMS evolving since less than 10 years for group IV (n=15).
  • Each progressive patient should have experienced a significant progression during the 2 years preceding the inclusion (with an estimated progression of the EDSS score of at least 0.5 point).
  • No clinical relapse during the past 3 months
  • Able to understand the objectives and procedures of the study, and who give inform consent.

Who cannot join

  • Any reason, which does not allow performing MRI: claustrophobia, pace-maker or intra-ocular foreign body for example.
  • For women: pregnancy, lactation, lack of efficient contraception. At visit 2, a positive pregnancy test will lead to exclude the patient.
  • Uncontrolled diabetes
  • Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal pulmonary or cardiac disease.
  • Positive HIV test
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual guidelines.
  • Other chronic neurological disease.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Saint Antoine Hospital

    Paris, 75012

  • Pitie Salpetriere Hospital

    Paris, 75013

Other trials in France

About this study

Official title: Imaging of Intracerebral Inflammation in the Progressive Phase of Multiple Sclerosis

In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied and compared: i) [18F]DPA-714, which bind to the peripheral benzodiazepine receptor (PBR), a target mainly expressed by activated microglial cells. This new ligand for PBR displays several advantages compared to the existing reference compound PK11195 in term of brain entrance, signal to noise ratio, and radiolabelling possibility with [18F] ii) [18F]-fluoro-desoxy-glucose ([18F]FDG), which should reflect glucose metabolism in activated immune cells in the white matter. Progressive MS patients (secondary progressive and primary progressive) will be compared to relapsing-remitting patients and to healthy volunteers. All subjects will pass a complete neurological evaluation and a multimodal MRI to document clinical disability and tissue injury. A clinical and radiological follow up will then be performed for a 2-year period. This study should help to understand the contribution of the intracerebral inflammation on the progression of disability and could provide a surrogate marker for further therapeutic trials in chronic progressive MS.

Read the detailed description

Study design This study is a prospective cross-sectional controlled multicentric clinical study in 45 MS patients and 20 controls.

Four groups of person will be included and compared:

  • Group I: 20 healthy volunteers aging from 18 to 65 years. These healthy volunteers will be matched for age and sex with patients (1/2).
  • Group II: 15 patients aging from 18 to 65 years with relapsing-remitting (RRMS), with less than 10 years of evolution since the first manifestation and no recent relapse.
  • Group III: 15 patients aging from 18 to 65 years with secondary progressive MS (SPMS), with less than 10 years of evolution since the occurrence of the secondary progressive phase.
  • Group III: 15 patients aging from 18 to 65 years with primary progressive MS (PPMS) diagnosed since less than 10 years.

Study centres MS patients and the 20 healthy volunteers will be recruited in the Hospital Pitie-Salpetriere

MS patients will be recruited in the Hospital Tenon

This study will be performed by complementary teams already collaborating on molecular imaging trials in MS (which assess neuronal loss or demyelination/remyelination): i) the "Centre d'Investigation Clinique" (Salpetriere hospital, Paris), which is strongly experienced in the coordination of clinical and translational research on MS; ii) the CENIR (centre for neuroimaging research, Salpetriere hospital, Paris) a specialized MRI centre for research on neurological diseases; iii) the SHFJ (DSV, CEA, ORSAY) which is a world class molecular imaging centre;

Study duration Per patient the study will last two years Per control the study will last up to 8 weeks

Being tested
18F-DPA-714 and 18F-FDG
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-DPA-714 and 18F-FDGDrug

    Positron emission tomography (PET) imaging following the injection of 2 radiotracers (here considered as the drugs): 1) 18F-DPA-714 ii) 18F-FDG. PET -18F-DPA-714, dose 5mCi (185MBq), will be injected via an arm intravenous catheter.

    18F-FDG , dose 5mci(185MBq), will be injected via an arm intravenous catheter.

Study groups in NCT02305264
Study groupRoleWhat they receive
PET -18F-DPA-714 and 18F-FDGExperimental18F-DPA-714, dose 5mCi (185MBq), will be injected via an arm intravenous catheter. 18F-FDG , dose 5mCi(185MBq), will be injected via an arm intravenous catheter.
Receives: Drug: 18F-DPA-714 and 18F-FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole brain Binding Potential (BP) of 18F-DPA-714

    Quantification of microglial compartmentalized inflammation within the brain by PET with 18F-DPA-714 in MS patients and healthy controls

    Measured: D0

Secondary outcomes (4)

  1. Binding potential of 18F-DPA-714 in segmented brain regions

    To compare binding potential of 18F-DPA-714 in segmented brain regions: white matter, gray matter, white matter lesions

    Measured: D0

  2. Binding potential of 18F-DPA-714 in subgroups of MS patients

    To compare binding potential of 18F-DPA-714 in subgroups of MS patients (secondary progressive, primary progressive, relapsing remitting)

    Measured: D0

  3. Predictive value of PET 18F-DPA-714 BP on neurological clinical metrics

    To determine the predictive value of brain microglial inflammation on subsequent neurological impairment progression after a follow up period of two years.

    Measured: 2 years

  4. Predictive value of PET 18F-DPA-714 BP on MRI metrics

    To determine the predictive value of brain microglial inflammation on subsequent brain atrophy progression after a follow up period of two years.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study start19 Mar 2012
  3. Primary completion10 Sep 2018
  4. Study completion10 Sep 2018

Resources

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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305264
Sponsor's protocol ID
P091001
Acronym
INFLASEP
Status last verified
Sep 2022
First submitted
25 Jan 2013
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Peyronneau MA, Kuhnast B, Nguyen DL, Jego B, Sayet G, Caille F, Lavisse S, Gervais P, Stankoff B, Sarazin M, Remy P, Bouilleret V, Leroy C, Bottlaender M. [18F]DPA-714: Effect of co-medications, age, sex, BMI and TSPO polymorphism on the human plasma input function. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3251-3264. doi: 10.1007/s00259-023-06286-1. Epub 2023 Jun 9.

    PubMed 37291448

  • Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6):e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.

    PubMed 36229188

  • Garcia-Lorenzo D, Lavisse S, Leroy C, Wimberley C, Bodini B, Remy P, Veronese M, Turkheimer F, Stankoff B, Bottlaender M. Validation of an automatic reference region extraction for the quantification of [18F]DPA-714 in dynamic brain PET studies. J Cereb Blood Flow Metab. 2018 Feb;38(2):333-346. doi: 10.1177/0271678X17692599. Epub 2017 Feb 9.

    PubMed 28178885

Questions about this trial

What is this clinical trial studying?

A study testing 18F-DPA-714 and 18F-FDG in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, Secondary Progressive, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

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 17 inclusion and 7 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole brain Binding Potential (BP) of 18F-DPA-714 (time frame: D0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305264, which also lists 3 linked publications.

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 16 Sep 2022.

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