An Integrated Radio-immunological Approach

Recruiting

• Conditions: Glioma, Malignant

• Registration Number: NCT05267509
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

Brief Summary

The most aggressive primary brain tumors in adults, glioblastomas, are characterized by a profound local and systemic immune suppression. During tumor progression, the infiltration of inflammatory leukocytes, especially of myeloid origin, endowed with immunosuppressive function is observed. Aim of this study is to evaluate myeloid cell infiltrate and iron metabolism in tumor-associated macrophages by combining a multimodal MRI imaging technique with immunophenotyping of the tumor microenvironment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-23
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients with histologic confirmation of malignant glioma
• Patients must be age >= 18 years
• Patients must be able to obtain an MRI scan with gadolinium contrast
• Patients must sign informed consent indicating that they are aware of the investigational nature of this study:

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate leukocyte/myeloid cell-infiltrate in gliomas by using a multimodal PET/MRI imaging technique	24 months	apply iron-sensitive MRI sequences in glioma patients to identify macrophage iron deposits as biomarker of in vivo immune suppression, and correlate these findings with 5-Ala intraoperative data and analysis of MG and BMDM infiltration.

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Padova, Italy