GliomaNCT07813741
Susceptibility-Weighted Imaging in Preoperative Grading of Cerebral Gliomas
An observational study of Glioma and Brain Neoplasms, run by Assiut University.
Trial summary
Gliomas are the most common primary brain tumors in adults. Determining whether a glioma is low-grade or high-grade before surgery is essential for surgical planning, choosing treatment pathways, and determining prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Brain Neoplasms, Cerebral Glioma
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Adult patients presenting to Assiut University Hospital with radiologically suspected cerebral gliomas on initial neuroimaging (CT or MRI) who are referred to the Department of Diagnostic and Interventional Radiology in collaboration with the Department of Neurosurgery, and scheduled for subsequent surgical resection or stereotactic biopsy.
Who may be able to join
- Adult patients aged 18 years and older.
- Neuroimaging (CT or MRI) findings suggestive of cerebral glioma.
- Patients scheduled for surgical resection or stereotactic biopsy.
Who cannot join
- Previous brain surgery for the same lesion.
- Previous cranial radiotherapy or chemotherapy.
- General contraindications to MRI (e.g., cardiac pacemakers, ferromagnetic implants, or severe claustrophobia).
- Poor-quality MRI examinations compromised by significant motion or susceptibility artifacts.
About this study
Official title: Diagnostic Value of Susceptibility-Weighted Imaging (SWI) in Preoperative Grading of Cerebral Gliomas
Gliomas are the most common primary brain tumors in adults. Determining whether a glioma is low-grade or high-grade before surgery is essential for surgical planning, choosing treatment pathways, and determining prognosis. Currently, definitive grading requires invasive tissue sampling through surgical resection or biopsy. Although conventional magnetic resonance imaging (MRI) is routinely performed, conventional sequences often show overlapping features between low-grade and high-grade tumors, limiting their ability to reliably predict tumor grade.
Susceptibility-weighted imaging (SWI) is an advanced MRI sequence sensitive to microscopic magnetic field distortions caused by blood products, calcification, and abnormal tumor blood vessels. On SWI, these features appear as intratumoral susceptibility signals (ITSS). Because high-grade gliomas typically display greater vascular proliferation and microhemorrhages than low-grade gliomas, quantifying ITSS may provide a non-invasive surrogate for tumor grade.
Read more
The primary purpose of this prospective observational study is to assess the diagnostic accuracy of SWI in the preoperative grading of cerebral gliomas, comparing imaging findings directly against histopathological examination according to the 2021 World Health Organization (WHO) Classification of Tumors of the Central Nervous System.
Adult participants with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy will undergo a standardized preoperative brain MRI protocol. This protocol incorporates SWI alongside conventional MRI sequences, diffusion-weighted imaging (DWI/ADC), and magnetic resonance spectroscopy (MRS). Two independent radiologists blinded to pathology will assess and grade intratumoral susceptibility signals. Following surgery, imaging-predicted grades will be compared with the final tissue pathology to determine the sensitivity, specificity, and overall diagnostic accuracy of SWI.
- Conditions
- Glioma, Brain Neoplasms, Cerebral Glioma
- Keywords
- Susceptibility-Weighted Imaging, SWI, Intratumoral Susceptibility Signals, ITSS, Glioma Grading, Preoperative Grading, Magnetic Resonance Imaging, MR Spectroscopy, Diffusion-Weighted Imaging
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Cerebral Glioma Cohort | Adult patients (≥18 years) presenting with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy. All participants undergo a standardized preoperative brain MRI protocol incorporating conventional sequences (T1, T2, FLAIR, pre- and post-contrast T1), diffusion-weighted imaging (DWI/ADC), magnetic resonance spectroscopy (MRS), and 3D susceptibility-weighted imaging (SWI). Intratumoral susceptibility signals (ITSS) on SWI are graded semi-quantitatively (grades 0 to 3) to differentiate low-grade (grades 0-1) from high-grade (grades 2-3) tumors. Final tumor grading is established via histopathological examination of the surgical resection or stereotactic biopsy specimen according to the 2021 WHO Classification of Tumors of the Central Nervous System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Susceptibility-Weighted Imaging (SWI)
Diagnostic accuracy is evaluated as the percentage of participants correctly categorized as having low-grade or high-grade cerebral gliomas using preoperative susceptibility-weighted imaging (SWI) intratumoral susceptibility signal (ITSS) grading, compared against the reference standard of histopathological examination according to the 2021 WHO Classification of Tumors of the Central Nervous System. ITSS is evaluated on a 4-point scale: Grade 0 (no ITSS), Grade 1 (1-5 dot-like/linear signals), Grade 2 (6-10 signals), and Grade 3 (>10 signals or confluent areas). Scores are dichotomized into low-grade (Grades 0-1) and high-grade (Grades 2-3) gliomas.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El-din Sayed Atta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813741
- Sponsor's protocol ID
- SWI in Cerebral Glioma Grading
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Susceptibility-Weighted Imaging (SWI) in Preoperative Grading of Cerebral Gliomas
- ClinicalTrials.gov ID
- NCT07813741
- Acronym / sponsor ID
- SWI in Cerebral Glioma Grading
- Conditions
- Glioma, Brain Neoplasms, Cerebral Glioma
- Keywords
- Susceptibility-Weighted Imaging, SWI, Intratumoral Susceptibility Signals, ITSS, Glioma Grading, Preoperative Grading, Magnetic Resonance Imaging, MR Spectroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gliomas are the most common primary brain tumors in adults. Determining whether a glioma is low-grade or high-grade before surgery is essential for surgical planning, choosing treatment pathways, and determining prognosis. Currently, definitive grading requires invasive tissue sampling through surgical resection or biopsy. Although conventional magnetic resonance imaging (MRI) is routinely performed, conventional sequences often show overlapping features between low-grade and high-grade tumors, limiting their ability to reliably predict tumor grade.
Susceptibility-weighted imaging (SWI) is an advanced MRI sequence sensitive to microscopic magnetic field distortions caused by blood products, calcification, and abnormal tumor blood vessels. On SWI, these features appear as intratumoral susceptibility signals (ITSS). Because high-grade gliomas typically display greater vascular proliferation and microhemorrhages than low-grade gliomas, quantifying ITSS may provide a non-invasive surrogate for tumor grade.
The primary purpose of this prospective observational study is to assess the diagnostic accuracy of SWI in the preoperative grading of cerebral gliomas, comparing imaging findings directly against histopathological examination according to the 2021 World Health Organization (WHO) Classification of Tumors of the Central Nervous System.
Adult participants with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy will undergo a standardized preoperative brain MRI protocol. This protocol incorporates SWI alongside conventional MRI sequences, diffusion-weighted imaging (DWI/ADC), and magnetic resonance spectroscopy (MRS). Two independent radiologists blinded to pathology will assess and grade intratumoral susceptibility signals. Following surgery, imaging-predicted grades will be compared with the final tissue pathology to determine the sensitivity, specificity, and overall diagnostic accuracy of SWI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Cerebral Glioma Cohort | – | –Adult patients (≥18 years) presenting with radiologically suspected cerebral gliomas who are scheduled for surgical resection or stereotactic biopsy. All participants undergo a standardized preoperative brain MRI protocol incorporating conventional sequences (T1, T2, FLAIR, pre- and post-contrast T1), diffusion-weighted imaging (DWI/ADC), magnetic resonance spectroscopy (MRS), and 3D susceptibility-weighted imaging (SWI). Intratumoral susceptibility signals (ITSS) on SWI are graded semi-quantitatively (grades 0 to 3) to differentiate low-grade (grades 0-1) from high-grade (grades 2-3) tumors. Final tumor grading is established via histopathological examination of the surgical resection or stereotactic biopsy specimen according to the 2021 WHO Classification of Tumors of the Central Nervous System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to Assiut University Hospital with radiologically suspected cerebral gliomas on initial neuroimaging (CT or MRI) who are referred to the Department of Diagnostic and Interventional Radiology in collaboration with the Department of Neurosurgery, and scheduled for subsequent surgical resection or stereotactic biopsy.
Key inclusion criteria (3 listed)
- Adult patients aged 18 years and older.
- Neuroimaging (CT or MRI) findings suggestive of cerebral glioma.
- Patients scheduled for surgical resection or stereotactic biopsy.
Key exclusion criteria (4 listed)
- Previous brain surgery for the same lesion.
- Previous cranial radiotherapy or chemotherapy.
- General contraindications to MRI (e.g., cardiac pacemakers, ferromagnetic implants, or severe claustrophobia).
- Poor-quality MRI examinations compromised by significant motion or susceptibility artifacts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of Susceptibility-Weighted Imaging (SWI)
Time frame: Baseline
Diagnostic accuracy is evaluated as the percentage of participants correctly categorized as having low-grade or high-grade cerebral gliomas using preoperative susceptibility-weighted imaging (SWI) intratumoral susceptibility signal (ITSS) grading, compared against the reference standard of histopathological examination according to the 2021 WHO Classification of Tumors of the Central Nervous System. ITSS is evaluated on a 4-point scale: Grade 0 (no ITSS), Grade 1 (1-5 dot-like/linear signals), Grade 2 (6-10 signals), and Grade 3 (>10 signals or confluent areas). Scores are dichotomized into low-grade (Grades 0-1) and high-grade (Grades 2-3) gliomas.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Brain Neoplasms, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Accuracy of Susceptibility-Weighted Imaging (SWI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.