Intraoperative Functional Ultrasound

Brain Tumor Clinical Trial

— FUSIMAGINE  

Official title:

Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656407
• Other study ID #: C14-66
• Secondary ID: 2015-A00661-48
• Status: Completed
• Phase: N/A
• Start date: February 11, 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Lesion
• Brain Neoplasms
• Brain Tumor

Intervention

Device:
• Ultrasound device
Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device

Locations

Country	Name	City	State
France	Pitié Salpetriere Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Demené 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI		During the surgery
Secondary	Sensitivity test of the new Doppler mode	fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.	During surgery
Secondary	In depth micro vessel localization	Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.	During surgery