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
Qualifiers
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 design
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.
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
IRCCS Ospedale San Raffaele
Lead sponsor
Fondazione Umberto Veronesi
Collaborator
Source ClinicalTrials.gov