Glymphatic Pathway in Brain Imaging

NCT05035251 | Unknown

• 1 other identifier: GP_2021_KNN
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the pathways of Gadolinium-based contrast agent (GBCA) in different brain compartments and evaluate correlations of GBCA enhancement with specific diseases.

Conditions

Glymphatic System

Keywords

glymphatic system; imaging of blood brain barrier

Outcome Measures

Primary Outcomes (1)

• Change of Signal-Intensity (SI)-Measurements with ROI in 3 specific MRI Scans

  Regions of interest for signal intensity measurements will be drawn in various cerebral fluid spaces, the size of the region of interest will depend on the target structure. Following structures will be measured: lateral and central aqueous chamber and vitreous body of the eye, distal optic nerve sheath, Meckel's cave, lateral ventricles and basal cisterns.

  Baseline (nativ scan), 20 minutes and 120 minutes after contrast media application

Study Arms (2)

experimental

patients with a condition

control

patients without condition

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients of a primary care clinic.

You may qualify if:

• Only patients with a clinical indication for GBCA
• Written informed consent
• No allergies to GBCA

You may not qualify if:

• Contraindications for MRI

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

Institute of Radiology and Nuclear Medicine

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Related Publications (10)

• Deike-Hofmann K, Reuter J, Haase R, Paech D, Gnirs R, Bickelhaupt S, Forsting M, Heussel CP, Schlemmer HP, Radbruch A. Glymphatic Pathway of Gadolinium-Based Contrast Agents Through the Brain: Overlooked and Misinterpreted. Invest Radiol. 2019 Apr;54(4):229-237. doi: 10.1097/RLI.0000000000000533.

  PMID: 30480554 BACKGROUND

• Taoka T, Naganawa S. Gadolinium-based Contrast Media, Cerebrospinal Fluid and the Glymphatic System: Possible Mechanisms for the Deposition of Gadolinium in the Brain. Magn Reson Med Sci. 2018 Apr 10;17(2):111-119. doi: 10.2463/mrms.rev.2017-0116. Epub 2018 Jan 25.

  PMID: 29367513 BACKGROUND

• Absinta M, Ha SK, Nair G, Sati P, Luciano NJ, Palisoc M, Louveau A, Zaghloul KA, Pittaluga S, Kipnis J, Reich DS. Human and nonhuman primate meninges harbor lymphatic vessels that can be visualized noninvasively by MRI. Elife. 2017 Oct 3;6:e29738. doi: 10.7554/eLife.29738.

  PMID: 28971799 BACKGROUND

• Rennels ML, Gregory TF, Blaumanis OR, Fujimoto K, Grady PA. Evidence for a 'paravascular' fluid circulation in the mammalian central nervous system, provided by the rapid distribution of tracer protein throughout the brain from the subarachnoid space. Brain Res. 1985 Feb 4;326(1):47-63. doi: 10.1016/0006-8993(85)91383-6.

  PMID: 3971148 BACKGROUND

• Iliff JJ, Wang M, Liao Y, Plogg BA, Peng W, Gundersen GA, Benveniste H, Vates GE, Deane R, Goldman SA, Nagelhus EA, Nedergaard M. A paravascular pathway facilitates CSF flow through the brain parenchyma and the clearance of interstitial solutes, including amyloid beta. Sci Transl Med. 2012 Aug 15;4(147):147ra111. doi: 10.1126/scitranslmed.3003748.

  PMID: 22896675 BACKGROUND

• Bedussi B, Almasian M, de Vos J, VanBavel E, Bakker EN. Paravascular spaces at the brain surface: Low resistance pathways for cerebrospinal fluid flow. J Cereb Blood Flow Metab. 2018 Apr;38(4):719-726. doi: 10.1177/0271678X17737984. Epub 2017 Oct 17.

  PMID: 29039724 BACKGROUND

• Smith AJ, Yao X, Dix JA, Jin BJ, Verkman AS. Test of the 'glymphatic' hypothesis demonstrates diffusive and aquaporin-4-independent solute transport in rodent brain parenchyma. Elife. 2017 Aug 21;6:e27679. doi: 10.7554/eLife.27679.

  PMID: 28826498 BACKGROUND

• Dobson H, Sharp MM, Cumpsty R, Criswell TP, Wellman T, Finucane C, Sullivan JM, Weller RO, Verma A, Carare RO. The perivascular pathways for influx of cerebrospinal fluid are most efficient in the midbrain. Clin Sci (Lond). 2017 Nov 13;131(22):2745-2752. doi: 10.1042/CS20171265. Print 2017 Nov 15.

  PMID: 29021222 BACKGROUND

• Iliff JJ, Wang M, Zeppenfeld DM, Venkataraman A, Plog BA, Liao Y, Deane R, Nedergaard M. Cerebral arterial pulsation drives paravascular CSF-interstitial fluid exchange in the murine brain. J Neurosci. 2013 Nov 13;33(46):18190-9. doi: 10.1523/JNEUROSCI.1592-13.2013.

  PMID: 24227727 BACKGROUND

• Manava P, Eckrich C, Luciani F, Schmidbauer J, Lell MM, Detmar K. Glymphatic System in Ocular Diseases: Evaluation of MRI Findings. AJNR Am J Neuroradiol. 2022 Jul;43(7):1012-1017. doi: 10.3174/ajnr.A7552. Epub 2022 Jun 30.

  PMID: 35772805 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Institute of Radiology and Nuclear Medicine, Klinikum Nuernberg

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: July 1, 2020
• Primary Completion: November 11, 2024
• Study Completion: December 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)