Clinical trial NCT03970499: Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors
Official title: Evaluation de l'intérêt de l'élastographie Ultrasonore et du Doppler Ultrasensible peropératoires Dans la Prise en Charge Chirurgicale Des Tumeurs cérébrales
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor, Primary
Keywords: glioma
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: ultrasound elastography measurements
timeFrame: 5 minutes, the day of surgery
measure: ultrasound ultrasensitive doppler measurements
timeFrame: 5 minutes, the day of surgery
Secondary outcomes:
measure: Comparaison between ultrasound results and histology
timeFrame: through study completion, an average of 1 year
measure: Correlation between ultrasound results and MRI
timeFrame: through study completion, an average of 1 year
measure: compare elasticity measurements obtained pre-operatively by passive MRI elastography with that obtained intraoperatively by ultrasound elastography.
timeFrame: baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: Ilyess ZEMMOURA
Study officials:
affiliation: CHRU Tours FRANCE
name: Ilyess ZEMMOURA, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lima GLO, Dezamis E, Corns R, Rigaux-Viode O, Moritz-Gasser S, Roux A, Duffau H, Pallud J. Surgical resection of incidental diffuse gliomas involving eloquent brain areas. Rationale, functional, epileptological and oncological outcomes. Neurochirurgie. 2017 Jun;63(3):250-258. doi: 10.1016/j.neuchi.2016.08.007. Epub 2017 Feb 1.
citation: Mahboob S, McPhillips R, Qiu Z, Jiang Y, Meggs C, Schiavone G, Button T, Desmulliez M, Demore C, Cochran S, Eljamel S. Intraoperative Ultrasound-Guided Resection of Gliomas: A Meta-Analysis and Review of the Literature. World Neurosurg. 2016 Aug;92:255-263. doi: 10.1016/j.wneu.2016.05.007. Epub 2016 May 10.
citation: Ferraro N, Barbarite E, Albert TR, Berchmans E, Shah AH, Bregy A, Ivan ME, Brown T, Komotar RJ. The role of 5-aminolevulinic acid in brain tumor surgery: a systematic review. Neurosurg Rev. 2016 Oct;39(4):545-55. doi: 10.1007/s10143-015-0695-2. Epub 2016 Jan 27.
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citation: Gerard IJ, Kersten-Oertel M, Petrecca K, Sirhan D, Hall JA, Collins DL. Brain shift in neuronavigation of brain tumors: A review. Med Image Anal. 2017 Jan;35:403-420. doi: 10.1016/j.media.2016.08.007. Epub 2016 Aug 24.
citation: Chauvet D, Imbault M, Capelle L, Demene C, Mossad M, Karachi C, Boch AL, Gennisson JL, Tanter M. In Vivo Measurement of Brain Tumor Elasticity Using Intraoperative Shear Wave Elastography. Ultraschall Med. 2016 Dec;37(6):584-590. doi: 10.1055/s-0034-1399152. Epub 2015 Apr 15.