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GliomaASL-TDDNCT07687277

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

An observational study of Glioma and Brain Neoplasms, run by Lanzhou University Second Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma, Brain Neoplasms
What is being tested?
Multiparametric MRI (3D-ASL and TDD-MRI)
How many people
75 participants
Where
1 siteChina
Study dates
1 Mar 2024to 30 Jul 2026
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
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

Other trials in China

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

Glioma is the most common primary malignant tumor of the central nervous system and is characterized by high invasiveness and a high recurrence rate. During postoperative follow-up after surgery and adjuvant therapy, newly developed or enlarged contrast-enhancing lesions may represent either true progression (TP) or treatment-related pseudoprogression (PsP). Because these entities require substantially different clinical management, accurate differentiation is essential.

Histopathological confirmation remains the reference standard but is invasive and not feasible for all patients. Conventional MRI has limited diagnostic accuracy because TP and PsP often demonstrate overlapping imaging characteristics. Advanced functional MRI techniques have therefore attracted increasing interest for improving noninvasive diagnosis.

Three-dimensional arterial spin labeling (3D-ASL) provides quantitative assessment of cerebral perfusion without exogenous contrast agents, whereas time-dependent diffusion MRI (TDD-MRI) characterizes tissue microstructure by measuring water diffusion under different diffusion times. These techniques provide complementary information regarding tumor vascularity and cellular architecture.

This is a single-center, prospective observational diagnostic accuracy study conducted at Lanzhou University Second Hospital. Approximately 75 consecutive postoperative glioma patients with suspected disease progression will be enrolled. All participants will undergo routine MRI, 3D-ASL, and TDD-MRI examinations according to a standardized imaging protocol. Quantitative imaging parameters, including relative cerebral blood flow (rCBF), ADC20Hz, ADC40Hz, Cellularity, and Diameter, will be extracted after image preprocessing and lesion segmentation.

Participants will not receive any additional therapeutic intervention as part of the study. Clinical management will be determined by treating physicians according to routine clinical practice. Final classification of TP or PsP will be established using pathological confirmation whenever available or comprehensive longitudinal clinical and imaging follow-up according to the RANO 2.0 criteria.

The primary objective is to evaluate the diagnostic performance of the combined 3D-ASL and TDD-MRI model using the area under the receiver operating characteristic curve (AUC). Secondary objectives include evaluating the diagnostic performance of individual imaging parameters, comparing diagnostic models, assessing calibration and clinical utility, determining interobserver agreement, and exploring the influence of clinicopathological factors on model performance.

The findings of this study are expected to establish a reliable, noninvasive multiparametric MRI strategy for differentiating TP from PsP after glioma surgery, thereby facilitating individualized postoperative management and reducing unnecessary invasive procedures.

Being tested
Multiparametric MRI (3D-ASL and TDD-MRI)
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
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.

  • 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.

Study groups in NCT07687277
Study groupRoleWhat they receive
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).
Receives: 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).
Receives: Diagnostic Test: Multiparametric MRI (3D-ASL and TDD-MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (15)
  1. AUC of rCBFmean

    Area under the receiver operating characteristic curve (AUC) of mean relative cerebral blood flow (rCBFmean) for differentiating true progression from pseudoprogression.

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

  2. AUC of rCBFmax

    Area under the receiver operating characteristic curve (AUC) of maximum relative cerebral blood flow (rCBFmax) for differentiating true progression from pseudoprogression.

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

  3. AUC of rCBFmin

    Area under the receiver operating characteristic curve (AUC) of minimum relative cerebral blood flow (rCBFmin) for differentiating true progression from pseudoprogression.

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

  4. AUC of ADC20Hz

    Area under the receiver operating characteristic curve (AUC) of ADC20Hz derived from time-dependent diffusion MRI for differentiating true progression from pseudoprogression.

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

  5. AUC of ADC40Hz

    Area under the receiver operating characteristic curve (AUC) of ADC40Hz derived from time-dependent diffusion MRI for differentiating true progression from pseudoprogression.

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

  6. AUC of Cellularity

    Area under the receiver operating characteristic curve (AUC) of the Cellularity parameter derived from time-dependent diffusion MRI for differentiating true progression from pseudoprogression.

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

  7. AUC of Diameter

    Area under the receiver operating characteristic curve (AUC) of the Diameter parameter derived from time-dependent diffusion MRI for differentiating true progression from pseudoprogression.

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

  8. Sensitivity of the Combined 3D-ASL and TDD-MRI Model

    Sensitivity of the combined 3D-ASL and TDD-MRI model for differentiating true progression from pseudoprogression.

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

  9. Specificity of the Combined 3D-ASL and TDD-MRI Model

    Specificity of the combined 3D-ASL and TDD-MRI model for differentiating true progression from pseudoprogression.

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

  10. Youden Index of the Combined 3D-ASL and TDD-MRI Model

    Youden index of the combined 3D-ASL and TDD-MRI model for differentiating true progression from pseudoprogression.

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

  11. Optimal Cutoff of the Combined 3D-ASL and TDD-MRI Model

    Optimal cutoff value of the combined 3D-ASL and TDD-MRI model determined from receiver operating characteristic curve analysis.

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

  12. AUC Difference Between the Combined Model and the Best Individual MRI Parameter

    Difference in AUC between the combined 3D-ASL and TDD-MRI model and the best-performing individual MRI parameter.

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

  13. Hosmer-Lemeshow Goodness-of-Fit P Value

    Hosmer-Lemeshow goodness-of-fit test P value for evaluating calibration of the combined 3D-ASL and TDD-MRI model.

    Measured: After completion of model construction and statistical analysis

  14. Clinical Net Benefit of the Combined 3D-ASL and TDD-MRI Model

    Clinical net benefit of the combined 3D-ASL and TDD-MRI model assessed using decision curve analysis.

    Measured: After completion of model construction and statistical analysis

  15. Interobserver Agreement for MRI Parameter Measurements

    Interobserver agreement for quantitative MRI parameter measurements assessed using the intraclass correlation coefficient (ICC).

    Measured: At image analysis after completion of MRI examinations

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start1 Mar 2024
  3. Primary completion28 Feb 2026
  4. Study completion30 Jul 2026 (estimated)

Resources

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07687277
Sponsor's protocol ID
LZU2H-MRI-2024A1221
Acronym
ASL-TDD
Status last verified
Jul 2026
First submitted
29 Jun 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the study data contain potentially identifiable clinical and imaging information. De-identified aggregate results may be reported in publications.

Questions about this trial

What is this clinical trial studying?

An observational study of Glioma and Brain Neoplasms, run by Lanzhou University Second Hospital at 1 site in China.

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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

AUC of the Combined 3D-ASL and TDD-MRI Model (time frame: From enrollment through completion of clinical and imaging follow-up (up to 12 months)). 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 7 Jul 2026.

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