- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335004
Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases
March 21, 2024 updated by: IRCCS Eugenio Medea
Valutazione Delle Vie "Glinfatiche" Utilizzando la Risonanza Magnetica Nelle Malattie Della Sostanza Bianca
The dilation of perivascular spaces can be the result of various etiopathogenetic processes.
White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies.
Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction.
Dilation of PVS can be associated with changes in white matter and microhemorrhages.
We want to study these etiopathogenetic phenomena by implementing specific MRI methods.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
Primary objective: the quantification of indirect magnetic resonance markers of altered waste drainage systems using validated scales in patients with white matter disease.
Secondary objective: the evaluation of white matter alterations in relation to the known anatomical glymphatic pathways by analyzing both structural and diffusion data.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lecco
-
Bosisio Parini, Lecco, Italy, 23842
- Scientific Institute IRCCS Eugenio Medea
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with white matter disease on T2 and FLAIR sequences are included in this study.
New MR sequences that can further identify subtle signal intensity changes within these white matter lesions will allow to further characterise them.
Some patients will require intravenous gadolinium as part of their diagnostic MR work-up.
Research MR sequences will also be acquired after gadolinium admininstration to further improve characterisation of the composition of white matter lesions.
Description
Inclusion Criteria:
- patients with and without white matter disease
- patients willing to participate in research with signed consent form
- no age limit (results will be age matched)
Exclusion Criteria:
- unwilling to participate in research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with white matter disease/healthy subjects
Patients with white matter disease due to genetic or acquired causes.
MRI with or without intravenous gadolinium will be performed
|
Patients will undergo a magnetic resonance imaging for clinical purposes to which additional sequences.
Post gadolinium research sequences will be acquired only if intravenous gadolinium needs to be administered for clinical purposes.
|
Patients with no white matter disease
Patients undergoing MRI with or without gadolinium for clinical diagnostic purposes, with no known white matter disease.
|
Patients will undergo a magnetic resonance imaging for clinical purposes to which additional sequences.
Post gadolinium research sequences will be acquired only if intravenous gadolinium needs to be administered for clinical purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of white matter lesions
Time Frame: once at recruitment
|
T1 values of lesions
|
once at recruitment
|
Number of perivascular spaces
Time Frame: once at recruitment
|
count of perivascular spaces and total volume in disease population
|
once at recruitment
|
Volume of parasagittal dural space
Time Frame: once at recruitment
|
volume of parasagittal dural space in disease population
|
once at recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8.
- Ma YJ, Fan S, Shao H, Du J, Szeverenyi NM, Young IR, Bydder GM. Use of Multiplied, Added, Subtracted and/or FiTted Inversion Recovery (MASTIR) pulse sequences. Quant Imaging Med Surg. 2020 Jun;10(6):1334-1369. doi: 10.21037/qims-20-568.
- Ma YJ, Shao H, Fan S, Lu X, Du J, Young IR, Bydder GM. New options for increasing the sensitivity, specificity and scope of synergistic contrast magnetic resonance imaging (scMRI) using Multiplied, Added, Subtracted and/or FiTted (MASTIR) pulse sequences. Quant Imaging Med Surg. 2020 Oct;10(10):2030-2065. doi: 10.21037/qims-20-795.
- Naganawa S, Nakane T, Kawai H, Taoka T. Lack of Contrast Enhancement in a Giant Perivascular Space of the Basal Ganglion on Delayed FLAIR Images: Implications for the Glymphatic System. Magn Reson Med Sci. 2017 Apr 10;16(2):89-90. doi: 10.2463/mrms.ci.2016-0114. Epub 2017 Jan 25. No abstract available.
- Rasmussen MK, Mestre H, Nedergaard M. The glymphatic pathway in neurological disorders. Lancet Neurol. 2018 Nov;17(11):1016-1024. doi: 10.1016/S1474-4422(18)30318-1.
- Hawkes CA, Hartig W, Kacza J, Schliebs R, Weller RO, Nicoll JA, Carare RO. Perivascular drainage of solutes is impaired in the ageing mouse brain and in the presence of cerebral amyloid angiopathy. Acta Neuropathol. 2011 Apr;121(4):431-43. doi: 10.1007/s00401-011-0801-7. Epub 2011 Jan 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
May 5, 2022
First Submitted That Met QC Criteria
March 21, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 926
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Disorder
-
University of California, DavisRecruitingPediatric DisorderUnited States
-
University of California, DavisCompleted
-
Ataturk UniversityCompleted
-
Memorial Sloan Kettering Cancer CenterRecruitingPediatric Disorder | Adult DiseaseUnited States
-
Children's Hospital of Fudan UniversityCompleted
-
Children's Hospital of Fudan UniversityCompletedPediatric Disorder | Capsule EndoscopyChina
-
CoapTechChildren's Hospital of Philadelphia; Columbia University; Children's National...RecruitingGastrostomy | Pediatric Disorder | Ultrasound | Gastrostomy ComplicationsUnited States
-
Massachusetts General HospitalTerminatedPediatric Bipolar Disorder | Pediatric OCDUnited States
-
Children's Mercy Hospital Kansas CityActive, not recruitingPediatric Feeding Disorder, Chronic | Pediatric Feeding Dysfunction, AcuteUnited States
-
Boston Children's HospitalRecruitingPediatric ALL | Motility DisorderUnited States
Clinical Trials on Magnetic resonance imaging
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Recruiting
-
University of California, San FranciscoTerminatedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
University of MichiganPhilips Healthcare; General ElectricCompleted
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI)Completed
-
M.D. Anderson Cancer CenterActive, not recruitingProstate Adenocarcinoma | Prostate CarcinomaUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy SubjectUnited States
-
Stanford UniversityTerminatedLaryngeal Neoplasms | Head and Neck Cancers | Larynx CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedMalignant Central Nervous System NeoplasmUnited States