Clinical trial · Interventional
Intraoperative Functional Ultrasound
Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)). Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent. This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity. Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition. The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI. Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Lesion | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultrasensitive Doppler
- description
- Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection
- interventionNames
- Device: Ultrasound device
Primary outcomes (1)
- measure
- Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI
- timeFrame
- During the surgery
Secondary outcomes (2)
- measure
- Sensitivity test of the new Doppler mode
- timeFrame
- During surgery
- description
- fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women, adults ( \> 18 years old) * Participants who have to undergo brain surgery, awake or under general anesthesia, for tumor or lesion resection (all types of tumors and lesions, cortical or subcortical), with programmed intraoperative ultrasound and cortical simulation mapping. * Consent form signed by the patient after being informed (written and oral) of the research protocol. * Patient affiliate to the social welfare system Exclusion Criteria: * Minors ( \< 18 years old) * Pregnant, parturient or breastfeeding women * Protected persons, under guardianship, or under any administrative or legal right and liberty revocation procedure * Patient without affiliation to the social welfare system
References
Publications (2)
- BACKGROUNDDemene C, Deffieux T, Pernot M, Osmanski BF, Biran V, Gennisson JL, Sieu LA, Bergel A, Franqui S, Correas JM, Cohen I, Baud O, Tanter M. Spatiotemporal Clutter Filtering of Ultrafast Ultrasound Data Highly Increases Doppler and fUltrasound Sensitivity. IEEE Trans Med Imaging. 2015 Nov;34(11):2271-85. doi: 10.1109/TMI.2015.2428634. Epub 2015 Apr 30. PMID 25955583
- RESULTImbault M, Chauvet D, Gennisson JL, Capelle L, Tanter M. Intraoperative Functional Ultrasound Imaging of Human Brain Activity. Sci Rep. 2017 Aug 4;7(1):7304. doi: 10.1038/s41598-017-06474-8. PMID 28779069