Clinical trial · Interventional
Insights Into the Pathophysiology of Neurovascular Uncoupling in Patients With Brain Lesions.
NCT06797661CI-TRIAL-00086222NVUCVRrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
Neurovascular uncoupling (NVU) represents a major source of potential bias for the identification of eloquent brain regions through activation procedures in blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). Same region shows proper pattern in glucose metabolism in victiny of brain lesions, investigated with positron emitted tomography with radiolabeled glucose (PET-FDG) This research project aims at investigating the mechanisms of NVU by using a multimodal noninvasive imaging approach in neurosurgical patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytic Tumor | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG-PET | Diagnostic Test | — | UNRESOLVED |
| Functional MRI | Diagnostic Test | — | UNRESOLVED |
| Structural MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Glioma patient
- description
- As compared to the pre-surgical evaluation that brain tumor patients routinely undergo in our institution, patients are asked to undergo some additional examinations.
- interventionNames
- Diagnostic Test: Functional MRI
- Diagnostic Test: FDG-PET
- Diagnostic Test: Structural MRI
Primary outcomes (8)
- measure
- Effects of Hypercapnia administration on fMRI data
- timeFrame
- end of acquisition ( group of 40 subject estimated at 10 months after first subjet acquisition)
- description
- For brain fRMI data: BOLD signal variation (Arbitrary Unit from a percent change from baseline).
- measure
- Effects of Hypercapnia administration on PET-FDG regional standardized data.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * patients in the study include prior imaging showing a potentially resectable intra-cerebral mass lesion. Patient has to be included before surgery, chemotherapy and radiation Exclusion Criteria: * previous brain surgery * respiratory failure * Asthma * Claustrophobia * Previous adverse reaction to gadovist (contrast agent) * Pregnancy and Breath feeding * Diabetes (type I and II)
References
Publications (34)
- BACKGROUNDBelanger M, Allaman I, Magistretti PJ. Brain energy metabolism: focus on astrocyte-neuron metabolic cooperation. Cell Metab. 2011 Dec 7;14(6):724-38. doi: 10.1016/j.cmet.2011.08.016. PMID 22152301
- BACKGROUNDAttwell D, Buchan AM, Charpak S, Lauritzen M, Macvicar BA, Newman EA. Glial and neuronal control of brain blood flow. Nature. 2010 Nov 11;468(7321):232-43. doi: 10.1038/nature09613. PMID 21068832
- BACKGROUNDKoehler RC, Roman RJ, Harder DR. Astrocytes and the regulation of cerebral blood flow. Trends Neurosci. 2009 Mar;32(3):160-9. doi: 10.1016/j.tins.2008.11.005. Epub 2009 Jan 21. PMID 19162338
- BACKGROUNDSokoloff L, Reivich M, Kennedy C, Des Rosiers MH, Patlak CS, Pettigrew KD, Sakurada O, Shinohara M. The [14C]deoxyglucose method for the measurement of local cerebral glucose utilization: theory, procedure, and normal values in the conscious and anesthetized albino rat. J Neurochem. 1977 May;28(5):897-916. doi: 10.1111/j.1471-4159.1977.tb10649.x. No abstract available. PMID 864466
- BACKGROUNDOgawa S, Lee TM, Kay AR, Tank DW. Brain magnetic resonance imaging with contrast dependent on blood oxygenation. Proc Natl Acad Sci U S A. 1990 Dec;87(24):9868-72. doi: 10.1073/pnas.87.24.9868. PMID 2124706
- BACKGROUNDSokoloff L. Relation between physiological function and energy metabolism in the central nervous system. J Neurochem. 1977 Jul;29(1):13-26. doi: 10.1111/j.1471-4159.1977.tb03919.x. No abstract available. PMID 407330
- BACKGROUNDBuxton RB. The physics of functional magnetic resonance imaging (fMRI). Rep Prog Phys. 2013 Sep;76(9):096601. doi: 10.1088/0034-4885/76/9/096601. Epub 2013 Sep 4. PMID 24006360
- BACKGROUNDMueller WM, Yetkin FZ, Hammeke TA, Morris GL 3rd, Swanson SJ, Reichert K, Cox R, Haughton VM. Functional magnetic resonance imaging mapping of the motor cortex in patients with cerebral tumors. Neurosurgery. 1996 Sep;39(3):515-20; discussion 520-1. doi: 10.1097/00006123-199609000-00015.