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

NCT07687277 | Active Not Recruiting

• 1 other identifier: LZU2H-MRI-2024A1221
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Brain Neoplasms

Keywords

Three-Dimensional Arterial Spin Labeling; 3D-ASL; Time-Dependent Diffusion MRI; TDD-MRI; True Progression; Pseudoprogression; Magnetic Resonance Imaging; Diagnostic Accuracy; Multiparametric MRI; Glioma Surgery; RANO; Cerebral Blood Flow; Diffusion MRI

Outcome Measures

Primary Outcomes (1)

• AUC of the Combined 3D-ASL and TDD-MRI Model

  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.

  From enrollment through completion of clinical and imaging follow-up (up to 12 months)

Secondary Outcomes (15)

• AUC of rCBFmean

  From enrollment through completion of clinical and imaging follow-up (up to 12 months)

• AUC of rCBFmax

  From enrollment through completion of clinical and imaging follow-up (up to 12 months)

• AUC of rCBFmin

  From enrollment through completion of clinical and imaging follow-up (up to 12 months)

• AUC of ADC20Hz

  From enrollment through completion of clinical and imaging follow-up (up to 12 months)

• AUC of ADC40Hz

  From enrollment through completion of clinical and imaging follow-up (up to 12 months)

Study Arms (2)

True Progression (TP)

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).

Diagnostic Test: Multiparametric MRI (3D-ASL and TDD-MRI)

Pseudoprogression (PsP)

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).

Diagnostic Test: Multiparametric MRI (3D-ASL and TDD-MRI)

Interventions

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

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.

Pseudoprogression (PsP); True Progression (TP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with histopathologically confirmed glioma who develop suspected tumor progression during postoperative follow-up at Lanzhou University Second Hospital and undergo routine MRI, three-dimensional arterial spin labeling (3D-ASL), and time-dependent diffusion MRI (TDD-MRI).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lanzhou University Second Hospital: lead

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 7, 2026
• Study Start: March 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: July 30, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)