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Active, not recruiting Observational

3D-ASL and TDD-MRI for True Progression and Pseudoprogression After Glioma Surgery

NCT07687277 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-03-01
Last updated
2026-07-07

Condition(s) studied

GliomaBrain Neoplasms

Investigational drug(s) / intervention(s)

Multiparametric MRI (3D-ASL and TDD-MRI)

Multiparametric MRI (3D-ASL and TDD-MRI): Participants undergo standardized multiparametric magnetic resonance imaging, including routine MRI, three-dimensional arterial spin labeling (3D-ASL), and time-dependent diffusion MRI (TDD-MRI). Quantitative perfusion and diffusion parameters are extracted for evaluation of their diagnostic performance in differentiating true progression from pseudoprogression after glioma surgery. No experimental therapeutic intervention is administered as part of the study.

Study summary

Background: Differentiating true progression (TP) from pseudoprogression (PsP) after glioma surgery remains a major clinical challenge because conventional magnetic resonance imaging (MRI) often cannot reliably distinguish these conditions.

Objective: This prospective observational diagnostic accuracy study aims to evaluate the value of multiparametric imaging based on three-dimensional arterial spin labeling (3D-ASL) combined with time-dependent diffusion MRI (TDD-MRI) for differentiating TP from PsP in postoperative glioma patients.

Methods: Consecutive adult patients with suspected tumor progression after glioma surgery will undergo routine MRI, 3D-ASL, and TDD-MRI examinations. Quantitative perfusion and diffusion parameters will be extracted, and a combined imaging model will be developed and evaluated. Final diagnosis will be established according to pathological findings when available or by longitudinal clinical and imaging follow-up based on the Response Assessment in Neuro-Oncology (RANO) criteria.

Expected Outcomes: The primary outcome is the diagnostic performance of the combined imaging model, assessed by the area under the receiver operating characteristic curve (AUC). The study is expected to provide a noninvasive imaging strategy for distinguishing TP from PsP and to support clinical decision-making during postoperative follow-up.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older. * Histopathologically confirmed glioma. * Received standard postoperative treatment or routine clinical treatment. * New or enlarged contrast-enhancing lesion on follow-up MRI suggestive of tumor progression. * Able to undergo routine MRI, three-dimensional arterial spin labeling (3D-ASL), and time-dependent diffusion MRI (TDD-MRI). * MRI image quality sufficient for image processing, registration, lesion segmentation, and quantitative parameter extraction. * Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: * Incomplete clinical, pathological, or imaging follow-up data. * MRI images with severe motion artifacts, susceptibility artifacts, or geometric distortion affecting image analysis. * Failure to complete routine MRI, 3D-ASL, or TDD-MRI examinations according to the study protocol. * Lesions too small or poorly defined for reliable three-dimensional volume-of-interest delineation and parameter extraction. * Any other condition judged by the investigators to make participation inappropriate.

Primary outcome measure(s)

  • AUC of the Combined 3D-ASL and TDD-MRI Model — From enrollment through completion of clinical and imaging follow-up (up to 12 months)
    Area under the receiver operating characteristic curve (AUC) of the combined three-dimensional arterial spin labeling (3D-ASL) and time-dependent diffusion MRI (TDD-MRI) model for differentiating true progression from pseudoprogression after glioma surgery.

Trial sites (1)

FacilityCityRegionStatus
Lanzhou University Second Hospital Lanzhou Gansu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07687277 on ClinicalTrials.gov ↗ ← All trials in China