CClinicalTrials.gg
Status unknownNCT04674579Updated Dec 19, 2020

Automatic Segmentation MRI Cerebral Glioma

An observational study in Cerebral Glioblastoma, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2020-12-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
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Study summary

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

Read the 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 .

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Conditions studied

  • Cerebral Glioblastoma

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Keywords

  • MRI automatic segmentation
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 188 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study will include 50 patients with cerebral gliomas identified by MRI A standardized multi-parametric MR protocol will be implemented for all patients. All sequences will be acquired on a 1.5T MR scanner.

Inclusion criteria

  • Patients with cerebral gliomas identified by MRI who will be treated surgically

Exclusion criteria

Exclusion Criteria:

  • Previously operated or biopsied gliomas.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DeviceMRI

    magnetic resonance imaging

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What researchers measure

Primary outcomes

  1. evaluate the role of automatic segmentation of cerebral gliomas in multi-sequence MR images in correlation with operative findings.

    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.

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 27651330 ↗
  • 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. PubMed 20231676 ↗
  • 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. PubMed 26777122 ↗
  • 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. PubMed 20862485 ↗
  • 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. PubMed 25036205 ↗
  • 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. PubMed 27001047 ↗
  • 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. PubMed 23790354 ↗
  • 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. PubMed 27806121 ↗
  • 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. PubMed 30415717 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04674579
Lead sponsor
Assiut University
Responsible party
Fatma Rabiee Ali Sedeek (assuit egypt, Assiut University) — Principal investigator
First posted
Dec 19, 2020
Start date
Jan 1, 2021 (estimated)
Primary completion
Feb 2023 (estimated)
Completion
Apr 2023 (estimated)
Last update
Dec 19, 2020

Study contacts

fatma sedeek
Contact
fatma.rabiee15@gmail.com
01066952726
Mostafa Mostafa
study director · Assiut University
Hosameldeen Metwalli
study director · Assiut University
Noha Attia
study director · Assiut University
fatma sedeek
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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