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

Primary Purpose

Brain Tumor, Primary

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
brain tumor resection
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor, Primary focused on measuring glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ilyess ZEMMOURARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

glial cerebral tumor

Arm Description

patient with an indication of glial cerebral tumor surgery

Outcomes

Primary Outcome Measures

ultrasound elastography measurements
Measure of cerebral ultrasound elasticity in three different areas: tumoral, peritumoral, and normal brain (in kPa)
ultrasound ultrasensitive doppler measurements
measurement perfusion by ultrasensitive doppler which consiste to map the power doppler amplitude ( % of vascularization)

Secondary Outcome Measures

Comparaison between ultrasound results and histology
histology criteria : type, gradation, neoangiogenesis molecular biology
Correlation between ultrasound results and MRI
MRI data : T1, hypersignal FLAIR, regional cerebral blood flow, diffusion

Full Information

First Posted
May 13, 2019
Last Updated
May 29, 2019
Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03970499
Brief Title
Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors
Acronym
ELASTOGLI
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Primary
Keywords
glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
glial cerebral tumor
Arm Type
Experimental
Arm Description
patient with an indication of glial cerebral tumor surgery
Intervention Type
Procedure
Intervention Name(s)
brain tumor resection
Intervention Description
Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery
Primary Outcome Measure Information:
Title
ultrasound elastography measurements
Description
Measure of cerebral ultrasound elasticity in three different areas: tumoral, peritumoral, and normal brain (in kPa)
Time Frame
5 minutes, the day of surgery
Title
ultrasound ultrasensitive doppler measurements
Description
measurement perfusion by ultrasensitive doppler which consiste to map the power doppler amplitude ( % of vascularization)
Time Frame
5 minutes, the day of surgery
Secondary Outcome Measure Information:
Title
Comparaison between ultrasound results and histology
Description
histology criteria : type, gradation, neoangiogenesis molecular biology
Time Frame
through study completion, an average of 1 year
Title
Correlation between ultrasound results and MRI
Description
MRI data : T1, hypersignal FLAIR, regional cerebral blood flow, diffusion
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilyess ZEMMOURA, MD PhD
Phone
2 18 37 08 13
Ext
00 33
Email
ilyess.zemmoura@univ-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine ROUSSEL
Phone
2 47 47 97 89
Ext
00 33
Email
roussel@med.univ-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilyess ZEMMOURA, MD PhD
Organizational Affiliation
CHRU Tours FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ilyess ZEMMOURA
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilyess ZEMMOURA, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28161011
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.
Results Reference
result
PubMed Identifier
27178235
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.
Results Reference
result
PubMed Identifier
26815631
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.
Results Reference
result
PubMed Identifier
26516822
Citation
Coburger J, Merkel A, Scherer M, Schwartz F, Gessler F, Roder C, Pala A, Konig R, Bullinger L, Nagel G, Jungk C, Bisdas S, Nabavi A, Ganslandt O, Seifert V, Tatagiba M, Senft C, Mehdorn M, Unterberg AW, Rossler 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.
Results Reference
result
PubMed Identifier
27585837
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.
Results Reference
result
PubMed Identifier
25876221
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.
Results Reference
result

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Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors

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