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Completed

NCT Number: NCT02656407

Intraoperative Functional Ultrasound

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pitié Salpetriere Hospital

Paris, Île-de-France Region, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound device

Device

Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device

Primary outcomes

  1. Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI

    Time frame: During the surgery

Secondary outcomes

  1. Sensitivity test of the new Doppler mode

    Time frame: During surgery

    fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.

  2. In depth micro vessel localization

    Time frame: During surgery

    Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

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

Acronym: FUSIMAGINE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2016
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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