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APT-weighted and Diffusion MRI for Characterizing Tumor Infiltration in High-Grade Gliomas

NCT07532031 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-15

No results posted yet for this study

Summary

High-grade gliomas are the most common primary malignant brain tumors and are characterized by infiltration of the surrounding brain tissue beyond the visible tumor margins. This infiltrative growth represents a major challenge for treatment planning and contributes to tumor recurrence. Conventional magnetic resonance imaging (MRI) is limited in its ability to distinguish tumor infiltration from non-tumoral changes such as vasogenic edema in the peri-tumoral region.

This prospective single-center observational study aims to improve the characterization of the peri-tumoral microenvironment in patients with suspected high-grade gliomas using advanced MRI techniques, including amide proton transfer-weighted (APTw) imaging and diffusion tensor imaging (DTI). These techniques provide complementary information about tissue composition and microstructure and may help identify areas of tumor infiltration that are not visible on conventional imaging.

APTw- and DTI-derived maps will be combined to generate imaging-derived maps describing the likelihood of tumor infiltration within the peri-tumoral region. These maps will be compared with histopathological findings obtained from tissue samples collected during biopsy or tumor resection performed as part of standard clinical care. Histological analyses will include assessment of tumor cellularity using hematoxylin and eosin staining and additional immunohistochemical markers routinely used in neuropathological evaluation. Patients will undergo routine clinical follow-up and the prognostic significance of the imaging-derived map will be assessed.

The overall goal of the study is to develop and validate imaging-based biomarkers capable of identifying infiltrated tissue within the peri-tumoral region. These findings may contribute to improved diagnostic accuracy and support future treatment planning strategies in patients with high-grade gliomas.

Conditions

Interventions

DIAGNOSTIC_TEST

Standard-of-care MRI data, including APT and diffusion imaging, will be analyzed to generate quantitative maps of tumor infiltration within the peri-tumoral region.

Advanced MRI data acquired as part of standard-of-care imaging, including amide proton transfer (APT) and diffusion tensor imaging (DTI), will be processed using dedicated post-hoc image analysis pipelines. A habitat-based clustering approach combining APT-derived MTRasym and DTI-derived mean diffusivity maps will be applied to generate a quantitative Tumor Infiltration Probability Map (TIPM). This imaging biomarker will be used to characterize peri-tumoral tissue heterogeneity and investigate tumor infiltration patterns for research purposes only.

Sponsors & Collaborators

  • Fondazione Umberto Veronesi

    collaborator OTHER

  • IRCCS Ospedale San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-10-31
Completion
2029-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07532031 on ClinicalTrials.gov