- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674579
Automatic Segmentation MRI Cerebral Glioma
The Added Value of Automatic Segmentation of Cerebral Gliomas in Multi-Sequence Magnetic Resonance Imaging (MRI)
Study Overview
Detailed Description
Gliomas are the most common primary brain tumors and are classified by their histopathological appearances using the World Health Organization (WHO) system into low-grade glioma (LGG) (grades I and II) and high-grade glioma (grade III anaplastic glioma and grade IV glioblastoma.
Gliomas, particularly high-grade, exhibit irregular growth patterns infiltrating the surrounding brain and thus showing irregular boundaries that may not be clear on conventional magnetic resonance images (MRI) MR images are visually inspected by radiologists, however, visual assessment is subjective, time consuming and prone to variability due to inter-rater differences. Accurate delineation of tumor boundaries as well as assessment of tumor volume are essential for treatment planning and monitoring treatment response . However, accurate delineation of the boundaries of glioma using subjective visual assessment is often difficult due to tumor heterogeneity and complexity, overlapping signal intensity with surrounding tissues and uneven tumor growth into nearby structures .
Compared to tumor volumetry, the routine visual evaluation of tumor size is based upon simple linear measurements of the gross tumor volume. These bi-dimensional measurements are often performed on a single MRI slice without volumetric measurements. These linear measurements are user-dependent and prone to errors due to increased measurement variability, especially in irregularly shaped lesions Computer-based fully-automatic tumor segmentation methods present a possible solution to these issues. The process is based upon information extraction from structural brain MRI images using a probabilistic tissue model to define the clear tumor boundaries using different MRI pulse sequences. These methods could accurately and rapidly identify glioma from surrounding normal brain tissue, and perform tumor volumetry, while eliminating intra-observer and inter-observer variability Internal changes within glioma, such as enhancement pattern and degeneration are crucial for identification of glioma grade, planning of treatment, monitoring of disease progression and evaluating the efficacy of therapy. In the process of automatic glioma segmentation, different parts of the glioma are characterized as solid (active) tumor, necrosis and peri-tumoral edema .
Automatic segmentation methods utilize artificial intelligence and machine learning techniques for extraction of information from multi-sequence MRI including, basically, T1W, Gadolinium enhanced T1W, T2W and FLAIR sequences .
Appropriate assessment of the extent of tumor resection plays an important role in the prognosis of glioma, since maximizing the extent of resection influences survival in these patients. Complete resection of enhancing tumor, defined as the removal of the final 1-2% of the tumor, seems to provide the most benefit in terms of patient's survival . Automatic segmentation could lead to better diagnosis and proper treatment planning through accurate tumor localization and classification .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: fatma sedeek
- Phone Number: 01066952726
- Email: fatma.rabiee15@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with cerebral gliomas identified by MRI who will be treated surgically
Exclusion Criteria:
- Previously operated or biopsied gliomas.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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evaluate the role of automatic segmentation of cerebral gliomas in multi-sequence MR images in correlation with operative findings.
Time Frame: baseline
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The aim of this study is to evaluate the role of automatic segmentation of cerebral gliomas in multi-sequence MR images using state-of-the-art methods for automatic segmentation and internal classification of brain tumors in correlation with operative findings.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mostafa Mostafa, Assiut University
- Study Director: Hosameldeen Metwalli, Assiut University
- Study Director: Noha Attia, Assiut University
- Principal Investigator: fatma sedeek, Assiut University
Publications and helpful links
General Publications
- Soltaninejad M, Yang G, Lambrou T, Allinson N, Jones TL, Barrick TR, Howe FA, Ye X. Automated brain tumour detection and segmentation using superpixel-based extremely randomized trees in FLAIR MRI. Int J Comput Assist Radiol Surg. 2017 Feb;12(2):183-203. doi: 10.1007/s11548-016-1483-3. Epub 2016 Sep 20.
- Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.
- Niyazi M, Brada M, Chalmers AJ, Combs SE, Erridge SC, Fiorentino A, Grosu AL, Lagerwaard FJ, Minniti G, Mirimanoff RO, Ricardi U, Short SC, Weber DC, Belka C. ESTRO-ACROP guideline "target delineation of glioblastomas". Radiother Oncol. 2016 Jan;118(1):35-42. doi: 10.1016/j.radonc.2015.12.003. Epub 2016 Jan 6.
- Tabatabai G, Stupp R, van den Bent MJ, Hegi ME, Tonn JC, Wick W, Weller M. Molecular diagnostics of gliomas: the clinical perspective. Acta Neuropathol. 2010 Nov;120(5):585-92. doi: 10.1007/s00401-010-0750-6. Epub 2010 Sep 23. Review.
- Kanaly CW, Mehta AI, Ding D, Hoang JK, Kranz PG, Herndon JE 2nd, Coan A, Crocker I, Waller AF, Friedman AH, Reardon DA, Sampson JH. A novel, reproducible, and objective method for volumetric magnetic resonance imaging assessment of enhancing glioblastoma. J Neurosurg. 2014 Sep;121(3):536-42. doi: 10.3171/2014.4.JNS121952. Epub 2014 Jul 18.
- Meier R, Knecht U, Loosli T, Bauer S, Slotboom J, Wiest R, Reyes M. Clinical Evaluation of a Fully-automatic Segmentation Method for Longitudinal Brain Tumor Volumetry. Sci Rep. 2016 Mar 22;6:23376. doi: 10.1038/srep23376.
- Gordillo N, Montseny E, Sobrevilla P. State of the art survey on MRI brain tumor segmentation. Magn Reson Imaging. 2013 Oct;31(8):1426-38. doi: 10.1016/j.mri.2013.05.002. Epub 2013 Jun 20. Review.
- Porz N, Habegger S, Meier R, Verma R, Jilch A, Fichtner J, Knecht U, Radina C, Schucht P, Beck J, Raabe A, Slotboom J, Reyes M, Wiest R. Fully Automated Enhanced Tumor Compartmentalization: Man vs. Machine Reloaded. PLoS One. 2016 Nov 2;11(11):e0165302. doi: 10.1371/journal.pone.0165302. eCollection 2016.
- Naceur MB, Saouli R, Akil M, Kachouri R. Fully Automatic Brain Tumor Segmentation using End-To-End Incremental Deep Neural Networks in MRI images. Comput Methods Programs Biomed. 2018 Nov;166:39-49. doi: 10.1016/j.cmpb.2018.09.007. Epub 2018 Sep 21.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRI cerebral glioma
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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