NCT07813741

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

September 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 6, 2026

Last Update Submit

September 6, 2026

Conditions

Keywords

Susceptibility-Weighted ImagingSWIIntratumoral Susceptibility SignalsITSSGlioma GradingPreoperative GradingMagnetic Resonance ImagingMR SpectroscopyDiffusion-Weighted Imaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adult patients aged 18 years and older.
  • Neuroimaging (CT or MRI) findings suggestive of cerebral glioma.
  • Patients scheduled for surgical resection or stereotactic biopsy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 6, 2026

First Posted

September 10, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09