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Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors

Evaluation de l'intérêt de l'élastographie Ultrasonore et du Doppler Ultrasensible peropératoires Dans la Prise en Charge Chirurgicale Des Tumeurs cérébrales

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03970499
Acronym
ELASTOGLI
Enrollment
20
Registered
2019-05-31
Start date
2019-04-15
Completion date
2023-04-15
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Primary

Keywords

glioma

Brief summary

Surgery for brain gliomas is usually guided by different imaging techniques including neuronavigation MRI and intraoperative ultrasound that do not allow visualization of the low-density peri-lesional tumor infiltration present in gliomas and from which the tumor recurs. Another important aspect in the management of glial tumors is the histological grade. The appearance of new vessels (called neo-angiogenesis) is one of the crucial steps in the life of these tumors, which signifies the transition to anaplasia. This neoangiogenesis is diagnosed during the anatomopathological analysis of the operative specimen, and may be suspected on preoperative MRI on the so-called infusion sequences. The objective of this project is to evaluate the potential of two ultrasound modalities - elastography and ultrasensitive Doppler - in helping the surgical management of brain tumors. Ultrasound elastography measures cerebral elasticity and thus indirectly the degree of tumor infiltration; while ultrasensitive Doppler measures intratumoral vascularization, and could therefore help in the diagnosis of tumor anaplasia.

Detailed description

Surgery for brain gliomas is usually guided by different imaging techniques including neuronavigation MRI and intraoperative ultrasound. Unfortunately, MRI and ultrasound do not allow visualization of the low-density peri-lesional tumor infiltration present in gliomas and from which the tumor recurs. Developing tools to identify this peritumoral infiltration zone is therefore a major issue in neuro-oncology. The consistency of brain tumors is a subjective criterion used in cerebral glioma surgery, the tumor area being firmer than the adjacent healthy brain. A pilot study was conducted from December 2012 to March 2014 by the Langevin Institute at La Pitié Salpêtrière. In this study, an intraoperative quantitative measurement of ultrasound elastography was performed on a cohort of patients with brain tumors. A significant difference between elasticity of low grade and high grade gliomas was found. However, in this study, no data on elasticity in a perilational infiltration zone is available. Another important aspect in the management of glial tumors is the histological grade. The appearance of new vessels (called neo-angiogenesis) is one of the crucial steps in the life of these tumors, which signifies the transition to anaplasia. This neoangiogenesis is diagnosed during the anatomopathological analysis of the operative specimen, and may be suspected on preoperative MRI on the so-called infusion sequences. The objective of this project is to evaluate the potential of two ultrasound modalities - elastography and ultrasensitive Doppler - in helping the surgical management of brain tumors, through intraoperative ultrasound. Ultrasound elastography measures cerebral elasticity and thus indirectly the degree of tumor infiltration; while ultrasensitive Doppler measures intratumoral vascularization, and can therefore help in the diagnosis of tumor anaplasia. Ultrasound elastography and ultrasensitive Doppler could enable us to more precisely target the more active tumoral territories (morphological criteria), to better identify the peri-lesional tumor infiltration in order to more precisely guide our resection procedure, and to provide additional information important for pathological analysis.

Interventions

PROCEDUREbrain tumor resection

Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient with an indication for surgery of a glial cerebral tumor * informed consent * age \> 18 * social security regime

Exclusion criteria

* patient with protection measures as tutelle or curatelle * pregnant woman or woman without contraception measure * patient under an exclusion period of another research

Design outcomes

Primary

MeasureTime frameDescription
ultrasound elastography measurements5 minutes, the day of surgeryMeasure of cerebral ultrasound elasticity in three different areas: tumoral, peritumoral, and normal brain (in kPa)
ultrasound ultrasensitive doppler measurements5 minutes, the day of surgerymeasurement perfusion by ultrasensitive doppler which consiste to map the power doppler amplitude ( % of vascularization)

Secondary

MeasureTime frameDescription
Comparaison between ultrasound results and histologythrough study completion, an average of 1 yearhistology criteria : type, gradation, neoangiogenesis molecular biology
Correlation between ultrasound results and MRIthrough study completion, an average of 1 yearMRI data : T1, hypersignal FLAIR, regional cerebral blood flow, diffusion
compare elasticity measurements obtained pre-operatively by passive MRI elastography with that obtained intraoperatively by ultrasound elastography.baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026