Clinical trial · Observational
3D-ASL and TDD-MRI for True Progression and Pseudoprogression After Glioma Surgery
Value of Multiparametric Imaging Based on Three-Dimensional Arterial Spin Labeling Combined With Time-Dependent Diffusion MRI in Differentiating True Progression From Pseudoprogression After Glioma Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric MRI (3D-ASL and TDD-MRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- True Progression (TP)
- description
- Participants with suspected postoperative glioma progression who are ultimately diagnosed with true progression based on histopathological findings when available or comprehensive longitudinal clinical and imaging follow-up according to the RANO 2.0 criteria. All participants undergo routine MRI, three-dimensional arterial spin labeling (3D-ASL), and time-dependent diffusion MRI (TDD-MRI).
- interventionNames
- Diagnostic Test: Multiparametric MRI (3D-ASL and TDD-MRI)
- label
- Pseudoprogression (PsP)
- description
- Participants with suspected postoperative glioma progression who are ultimately diagnosed with pseudoprogression based on histopathological findings when available or comprehensive longitudinal clinical and imaging follow-up according to the RANO 2.0 criteria. All participants undergo routine MRI, three-dimensional arterial spin labeling (3D-ASL), and time-dependent diffusion MRI (TDD-MRI).
- interventionNames
- Diagnostic Test: Multiparametric MRI (3D-ASL and TDD-MRI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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