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

Sponsor
IRCCS Ospedale San Raffaele
Study ID
NCT07532031
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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. — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Apr 15, 2026
Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Patients with radiologically suspected, treatment-naïve high-grade gliomas
    Adult patients with suspected high-grade glioma undergoing standard-of-care MRI evaluation and neurosurgical procedures (stereotactic biopsy or surgical resection). Imaging data and tissue samples will be collected and analyzed to investigate imaging biomarkers of tumor infiltration.

Primary Outcome Measure

Correlation Between TIPM Values and Tumor Cell Density [ Time Frame: At the time of surgery ]

Central Contacts

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