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Automatic Segmentation MRI Cerebral Glioma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - Previously operated or biopsied gliomas.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04674579
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mostafa MostafaHosameldeen MetwalliNoha Attiafatma sedeek
Principal Investigator Affiliation Assiut UniversityAssiut UniversityAssiut UniversityAssiut University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cerebral Glioblastoma
Additional Details

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 .

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

fatma sedeek

[email protected]

01066952726

For additional contact information, you can also visit the trial on clinicaltrials.gov.