Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors

NCT03970499 | Completed DMC

• 1 other identifier: PHA017-IZ/ELASTOGLI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor, Primary

Keywords

glioma

Outcome Measures

Primary Outcomes (2)

• ultrasound elastography measurements

  Measure of cerebral ultrasound elasticity in three different areas: tumoral, peritumoral, and normal brain (in kPa)

  5 minutes, the day of surgery

• ultrasound ultrasensitive doppler measurements

  measurement perfusion by ultrasensitive doppler which consiste to map the power doppler amplitude ( % of vascularization)

  5 minutes, the day of surgery

Secondary Outcomes (3)

• Comparaison between ultrasound results and histology

  through study completion, an average of 1 year

• Correlation between ultrasound results and MRI

  through study completion, an average of 1 year

• compare elasticity measurements obtained pre-operatively by passive MRI elastography with that obtained intraoperatively by ultrasound elastography.

  baseline

Study Arms (1)

glial cerebral tumor

EXPERIMENTAL

patient with an indication of glial cerebral tumor surgery

Procedure: brain tumor resection

Interventions

brain tumor resection PROCEDURE

Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery

glial cerebral tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patient with protection measures as "tutelle or curatelle"
• pregnant woman or woman without contraception measure

Sponsors & Collaborators

• University Hospital, Tours: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Ilyess ZEMMOURA

Tours, 37000, France

Location

Related Publications (6)

• 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.

  PMID: 28161011 RESULT

• 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.

  PMID: 27178235 RESULT

• 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.

  PMID: 26815631 RESULT

• 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.

  PMID: 26516822 RESULT

• 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.

  PMID: 27585837 RESULT

• 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.

  PMID: 25876221 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Ilyess ZEMMOURA, MD PhD

  CHRU Tours FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 31, 2019
• Study Start: April 15, 2019
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)