Multiple Sclerosis Clinical Trial
Official title:
Evaluation of the Degree of Demyelination and Remyelination in Multiple Sclerosis (MS) Detected by Brain Positron Emission Tomography With Amyloid Markers (PET-CT 18F-Florbetaben) and Comparison With MRI Findings
NCT number | NCT05783934 |
Other study ID # | CE 2585 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2021 |
Est. completion date | December 2024 |
The goal of this clinical trial study is to evaluate the presence of relationships between PET and MRI images indicative of chronic inflammatory activity (smoldering plaques), apparent absence of inflammatory activity (silent plaques without microglial rim), or indicative of more recent inflammatory activity, in contrast-enhanced areas or in T2/Flair-positive areas of not distant onset in patients diagnosed with progressive (secondary or primary) stage multiple sclerosis and in patients in relapse and remission. Laboratory analysis of serum markers will be performed: neuronal and glial cytoskeletal proteins (e.g., Nf-L, pN-FH, GFAP), and the levels of neurotrophic factors (e.g., BDNF, GDNF) and cytokines (e.g., TNFα, IL-6, IL-1β, interferon) will be evaluated.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - progressive stage of multiple sclerosis (both secondary and primary, SMP) - patients in relapsing-remitting multiple sclerosis (RRMS) Exclusion Criteria: - a disability greater than 7 - patients with a cognitive impairment interfering with full study participation (Minimental score less than 24) - patients with internal medical problems that in the opinion of the investigator may interfere with full participation and collaboration - inability to undergo MRI or PET examinations - ongoing pregnancy and lactation |
Country | Name | City | State |
---|---|---|---|
Italy | ICS Maugeri SpA SB IRCCS | Pavia | PV |
Lead Sponsor | Collaborator |
---|---|
Istituti Clinici Scientifici Maugeri SpA |
Italy,
Absinta M, Lassmann H, Trapp BD. Mechanisms underlying progression in multiple sclerosis. Curr Opin Neurol. 2020 Jun;33(3):277-285. doi: 10.1097/WCO.0000000000000818. — View Citation
Absinta M, Sati P, Fechner A, Schindler MK, Nair G, Reich DS. Identification of Chronic Active Multiple Sclerosis Lesions on 3T MRI. AJNR Am J Neuroradiol. 2018 Jul;39(7):1233-1238. doi: 10.3174/ajnr.A5660. Epub 2018 May 3. — View Citation
Absinta M, Sati P, Masuzzo F, Nair G, Sethi V, Kolb H, Ohayon J, Wu T, Cortese ICM, Reich DS. Association of Chronic Active Multiple Sclerosis Lesions With Disability In Vivo. JAMA Neurol. 2019 Dec 1;76(12):1474-1483. doi: 10.1001/jamaneurol.2019.2399. Erratum In: JAMA Neurol. 2019 Dec 1;76(12):1520. — View Citation
Bagnato F, Gauthier SA, Laule C, Moore GRW, Bove R, Cai Z, Cohen-Adad J, Harrison DM, Klawiter EC, Morrow SA, Oz G, Rooney WD, Smith SA, Calabresi PA, Henry RG, Oh J, Ontaneda D, Pelletier D, Reich DS, Shinohara RT, Sicotte NL; NAIMS Cooperative. Imaging Mechanisms of Disease Progression in Multiple Sclerosis: Beyond Brain Atrophy. J Neuroimaging. 2020 May;30(3):251-266. doi: 10.1111/jon.12700. — View Citation
Bodini B, Stankoff B. PET is necessary to make the next step forward in understanding MS pathophysiology - Yes. Mult Scler. 2019 Jul;25(8):1086-1087. doi: 10.1177/1352458519828298. Epub 2019 Feb 27. No abstract available. — View Citation
Bodini B, Veronese M, Garcia-Lorenzo D, Battaglini M, Poirion E, Chardain A, Freeman L, Louapre C, Tchikviladze M, Papeix C, Dolle F, Zalc B, Lubetzki C, Bottlaender M, Turkheimer F, Stankoff B. Dynamic Imaging of Individual Remyelination Profiles in Multiple Sclerosis. Ann Neurol. 2016 May;79(5):726-738. doi: 10.1002/ana.24620. — View Citation
Calvi A, Haider L, Prados F, Tur C, Chard D, Barkhof F. In vivo imaging of chronic active lesions in multiple sclerosis. Mult Scler. 2022 Apr;28(5):683-690. doi: 10.1177/1352458520958589. Epub 2020 Sep 23. — View Citation
Chen MK, Mecca AP, Naganawa M, Finnema SJ, Toyonaga T, Lin SF, Najafzadeh S, Ropchan J, Lu Y, McDonald JW, Michalak HR, Nabulsi NB, Arnsten AFT, Huang Y, Carson RE, van Dyck CH. Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging. JAMA Neurol. 2018 Oct 1;75(10):1215-1224. doi: 10.1001/jamaneurol.2018.1836. — View Citation
Chincarini A, Peira E, Morbelli S, Pardini M, Bauckneht M, Arbizu J, Castelo-Branco M, Busing KA, de Mendonca A, Didic M, Dottorini M, Engelborghs S, Ferrarese C, Frisoni GB, Garibotto V, Guedj E, Hausner L, Hugon J, Verhaeghe J, Mecocci P, Musarra M, Queneau M, Riverol M, Santana I, Guerra UP, Nobili F. Semi-quantification and grading of amyloid PET: A project of the European Alzheimer's Disease Consortium (EADC). Neuroimage Clin. 2019;23:101846. doi: 10.1016/j.nicl.2019.101846. Epub 2019 May 4. — View Citation
Hogel H, Rissanen E, Vuorimaa A, Airas L. Positron emission tomography imaging in evaluation of MS pathology in vivo. Mult Scler. 2018 Oct;24(11):1399-1412. doi: 10.1177/1352458518791680. Epub 2018 Aug 9. — View Citation
Kaunzner UW, Kang Y, Zhang S, Morris E, Yao Y, Pandya S, Hurtado Rua SM, Park C, Gillen KM, Nguyen TD, Wang Y, Pitt D, Gauthier SA. Quantitative susceptibility mapping identifies inflammation in a subset of chronic multiple sclerosis lesions. Brain. 2019 Jan 1;142(1):133-145. doi: 10.1093/brain/awy296. — View Citation
Maggi P, Sati P, Nair G, Cortese ICM, Jacobson S, Smith BR, Nath A, Ohayon J, van Pesch V, Perrotta G, Pot C, Theaudin M, Martinelli V, Scotti R, Wu T, Du Pasquier R, Calabresi PA, Filippi M, Reich DS, Absinta M. Paramagnetic Rim Lesions are Specific to Multiple Sclerosis: An International Multicenter 3T MRI Study. Ann Neurol. 2020 Nov;88(5):1034-1042. doi: 10.1002/ana.25877. Epub 2020 Sep 9. — View Citation
Mehta V, Pei W, Yang G, Li S, Swamy E, Boster A, Schmalbrock P, Pitt D. Iron is a sensitive biomarker for inflammation in multiple sclerosis lesions. PLoS One. 2013;8(3):e57573. doi: 10.1371/journal.pone.0057573. Epub 2013 Mar 14. — View Citation
Stankoff B, Poirion E, Tonietto M, Bodini B. Exploring the heterogeneity of MS lesions using positron emission tomography: a reappraisal of their contribution to disability. Brain Pathol. 2018 Sep;28(5):723-734. doi: 10.1111/bpa.12641. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PET outcome | The main endpoint is to differentiate PET outcome in progressive forms compared to relapsing-remitting forms. It is expected that in RRMS forms, the degree of demyelination and of remyelination is lower and higher, respectively, than in progressive forms. | this evaluation is performed at the time of recruitment | |
Secondary | correlation between PET data and MRI images and degree of disability | Correlations between "smoldering plaques" identified on MRI and their degree of demyelination and remyelination detected on amyloid PET (Relationship between global susceptibility of Rim+ lesions and semi-quantitative data of tracer uptake in the region of interest)
Correlations between T2/Flair positive plaques and degrees of demyelination and remyelination Relationship between number and extent of smoldering plaques and degree of disability Relationship between extent of demyelination detected by amyloid PET and disability Relationship between extent of remyelination detected by PET and disability Relation between axonal damage found by laboratory tests (neurofilaments) and the presence of pro-inflammatory cytokines and MRI evidence of axonal impairment (atrophy); activation of innate immunity (microglial rem); presence of demyelination and remyelination at PET |
this evaluation is performed at the time of recruitment |
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