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Brain Tumor, PrimaryELASTOGLINCT03970499

Ultrasound Elastography and Ultrasentive Doppler for Surgery of Brain Tumors

A study testing brain tumor resection in people with Brain Tumor, Primary, run by University Hospital, Tours at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Tumor, Primary
What is being tested?
brain tumor resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
15 Apr 2019to 15 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Ilyess ZEMMOURA

    Tours, 37000

Other trials in France

About this study

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

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.

Read more

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.

Read the 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.

Being tested
brain tumor resection
Keywords
glioma
Medical subject headings
Brain Neoplasms, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brain tumor resectionProcedure or surgery

    Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery

Study groups in NCT03970499
Study groupRoleWhat they receive
glial cerebral tumorExperimentalpatient with an indication of glial cerebral tumor surgery
Receives: Procedure: brain tumor resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ultrasound elastography measurements

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

    Measured: 5 minutes, the day of surgery

  2. ultrasound ultrasensitive doppler measurements

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

    Measured: 5 minutes, the day of surgery

Secondary outcomes (3)

  1. Comparaison between ultrasound results and histology

    histology criteria : type, gradation, neoangiogenesis molecular biology

    Measured: through study completion, an average of 1 year

  2. Correlation between ultrasound results and MRI

    MRI data : T1, hypersignal FLAIR, regional cerebral blood flow, diffusion

    Measured: through study completion, an average of 1 year

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start15 Apr 2019
  3. Primary completion15 Apr 2023
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970499
Sponsor's protocol ID
PHA017-IZ/ELASTOGLI
Acronym
ELASTOGLI
Status last verified
Nov 2023
First submitted
13 May 2019
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28161011

  • 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.

    PubMed 27178235

  • 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.

    PubMed 26815631

  • 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.

    PubMed 26516822

  • 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.

    PubMed 27585837

  • 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.

    PubMed 25876221

Questions about this trial

What is this clinical trial studying?

A study testing brain tumor resection in people with Brain Tumor, Primary, run by University Hospital, Tours at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ultrasound elastography measurements (time frame: 5 minutes, the day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970499, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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