APT-weighted and Diffusion MRI for Characterizing Tumor Infiltration in High-Grade Gliomas
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Ospedale San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (both male and female, >= 18 years old)
Previously acquired MRI suggestive for the presence of high-grade glioma
Treatment-naïve status, defined as no prior surgical, radiotherapeutic, or systemic oncological treatment for the index brain lesion.
Indication for biopsy or tumor resection
Disqualifiers
Pregnancy (to be excluded through a human chorionic gonadotropin pregnancy test performed on urine or serum when childbearing potential) and / or lactation.
Presence of any other co-existing condition (such as serious systemic illness, including uncontrolled intercurrent infection, uncontrolled malignancy, significant renal or hepatic disease, or psychiatric/social situations) which might, in the judgment of the investigator, increase the risks to the subject or limit compliance with study requirements
Inability to undergo surgical procedures
Severe hepatic impairment, defined as the presence of two or more of the following parameters (assessed within 40 days): bilirubin ≥3 mg/dL, albumin <2.8 g/dL, International normalized ratio >2.3 with no history of anticoagulant therapy, platelet count < 100 109/L, AST ≥ 400 U/L, ALT ≥400 U/L, presence of ascites.
Trial population
Adult patients (≥18 years) with radiologically suspected, treatment-naïve high-grade gliomas undergoing standard-of-care neurosurgical procedures (stereotactic biopsy or surgical resection) and pre-operative MRI evaluation will be prospectively enrolled. All participants will receive routine clinical management and follow-up according to standard clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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 testAdvanced 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients with radiologically suspected, treatment-naïve high-grade gliomas1 intervention
Trial outcomes
Primary outcomes
1
Correlation Between TIPM Values and Tumor Cell Density
Correlation coefficients between voxel-wise Tumor Infiltration Probability Map (TIPM) values within the non-contrast-enhancing tumor component and tumor cell density (cells/mm²) measured on hematoxylin and eosin-stained histological sections.
Time frame
At the time of surgerySecondary outcomes
1
Correlation Between TIPM Values and Ki-67 Proliferation Index
Correlation coefficients between voxel-wise Tumor Infiltration Probability Map (TIPM) values within the non-contrast-enhancing tumor component and Ki-67 proliferation index measured on histological sections.
Time frame
At the time of surgery2
Spatial Overlap Between TIPM-Defined Tumor Infiltration and Tumor Recurrence
Spatial overlap, measured using the Dice similarity coefficient, between baseline TIPM-defined tumor infiltration volume and tumor recurrence segmented on follow-up MRI.
Time frame
At the time of radiological recurrence (according to RANO criteria)3
Association Between TIPM-Derived Tumor Infiltration Volume and Survival Outcomes
Hazard ratio for progression-free survival (PFS) and overall survival (OS) associated with TIPM-derived tumor infiltration volume. PFS and OS are defined as time from surgery to disease progression or death.
Time frame
From the date of surgery up to 36 monthsLocations
Sponsors and contacts
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IRCCS Ospedale San Raffaele
Lead sponsor
Fondazione Umberto Veronesi
Collaborator
Source ClinicalTrials.gov
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