NCT07532031Not yet recruiting
APT-weighted and Diffusion MRI for Characterizing Tumor Infiltration in High-Grade Gliomas
Characterization of Peri-tumoral Microenvironment in High-grade Gliomas Through the Combined Use of APT-weighted Imaging and Diffusion MRI
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Diseases
- Glioblastoma
- NCT number
- NCT07532031
What you commit to
- Study type: Observational
- Planned participants: 20
- From 1 Apr 2026 to the primary completion date, 31 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to undergo surgical procedures
Other illness
- 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
Lab values
- Pregnancy (to be excluded through a human chorionic gonadotropin pregnancy test performed on urine or serum when childbearing potential) and / or lactation.
- Contraindications to MRI because of:
- Claustrophobia II. Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) III. Sickle cell disease IV. Renal failure or reduced renal function, as determined by Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73 m\^2 based on a serum creatinine level obtained within 40 days prior to registration
- 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.
Who the study is looking for
- 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
- Willingness to participate to the study and ability to sign informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.