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出境医 / 临床实验 / Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors (ELASTOGLI)

Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors (ELASTOGLI)

Study Description
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.


Condition or disease Intervention/treatment Phase
Brain Tumor, Primary Procedure: brain tumor resection Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation de l'intérêt de l'élastographie Ultrasonore et du Doppler Ultrasensible peropératoires Dans la Prise en Charge Chirurgicale Des Tumeurs cérébrales
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: glial cerebral tumor
patient with an indication of glial cerebral tumor surgery
 Procedure: brain tumor resection
Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery
Outcome Measures
Primary Outcome Measures :
  1. ultrasound elastography measurements [ Time Frame: 5 minutes, the day of surgery ]
    Measure of cerebral ultrasound elasticity in three different areas: tumoral, peritumoral, and normal brain (in kPa)

  2. ultrasound ultrasensitive doppler measurements [ Time Frame: 5 minutes, the day of surgery ]
    measurement perfusion by ultrasensitive doppler which consiste to map the power doppler amplitude ( % of vascularization)


Secondary Outcome Measures :
  1. Comparaison between ultrasound results and histology [ Time Frame: through study completion, an average of 1 year ]
    histology criteria : type, gradation, neoangiogenesis molecular biology

  2. Correlation between ultrasound results and MRI [ Time Frame: through study completion, an average of 1 year ]
    MRI data : T1, hypersignal FLAIR, regional cerebral blood flow, diffusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ilyess ZEMMOURA, MD PhD 2 18 37 08 13 ext 00 33 ilyess.zemmoura@univ-tours.fr
Contact: Catherine ROUSSEL 2 47 47 97 89 ext 00 33 roussel@med.univ-tours.fr

Locations
Layout table for location information
France
Ilyess ZEMMOURA Recruiting
Tours, France, 37000
Contact: Ilyess ZEMMOURA, MD         
Sponsors and Collaborators
University Hospital, Tours
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Ilyess ZEMMOURA, MD PhD CHRU Tours FRANCE
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • ultrasound elastography measurements [ Time Frame: 5 minutes, the day of surgery ]
    Measure of cerebral ultrasound elasticity in three different areas: tumoral, peritumoral, and normal brain (in kPa)
  • ultrasound ultrasensitive doppler measurements [ Time Frame: 5 minutes, the day of surgery ]
    measurement perfusion by ultrasensitive doppler which consiste to map the power doppler amplitude ( % of vascularization)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Comparaison between ultrasound results and histology [ Time Frame: through study completion, an average of 1 year ]
    histology criteria : type, gradation, neoangiogenesis molecular biology
  • Correlation between ultrasound results and MRI [ Time Frame: through study completion, an average of 1 year ]
    MRI data : T1, hypersignal FLAIR, regional cerebral blood flow, diffusion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors
Official Title  ICMJE Evaluation de l'intérêt de l'élastographie Ultrasonore et du Doppler Ultrasensible peropératoires Dans la Prise en Charge Chirurgicale Des Tumeurs cérébrales
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Tumor, Primary
Intervention  ICMJE Procedure: brain tumor resection
Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery
Study Arms  ICMJE Experimental: glial cerebral tumor
patient with an indication of glial cerebral tumor surgery
Intervention: Procedure: brain tumor resection
Publications *
  • 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.
  • 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. Review.
  • 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. Review.
  • Coburger J, Merkel A, Scherer M, Schwartz F, Gessler F, Roder C, Pala A, König R, Bullinger L, Nagel G, Jungk C, Bisdas S, Nabavi A, Ganslandt O, Seifert V, Tatagiba M, Senft C, Mehdorn M, Unterberg AW, Rössler K, Wirtz CR. Low-grade Glioma Surgery in Intraoperative Magnetic Resonance Imaging: Results of a Multicenter Retrospective Assessment of the German Study Group for Intraoperative Magnetic Resonance Imaging. Neurosurgery. 2016 Jun;78(6):775-86. doi: 10.1227/NEU.0000000000001081.
  • 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. Review.
  • 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. Epub 2015 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970499
Other Study ID Numbers  ICMJE PHA017-IZ/ELASTOGLI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Ilyess ZEMMOURA, MD PhD CHRU Tours FRANCE
PRS Account University Hospital, Tours
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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