An Integrated Radio-immunological Approach

Glioma, Malignant Clinical Trial

— IMMUNO-IMAGING  

Official title:

Identification of the Immuno Suppressive Characteristics of Glioma Patients by an Integrated Radio-immunological Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267509
• Other study ID #: 2021/27
• Status: Recruiting
• Start date: February 23, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2023
• Source: Istituto Oncologico Veneto IRCCS
• Contact: Susanna Mandruzzato, PhD
• Phone: +39 049 8215898
• Email: susanna.mandruzzato[@]unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

Locations

Country	Name	City	State
Italy	University Hospital	Florence
Italy	University Hospital	Padova

Sponsors (3)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS	Azienda Ospedaliera di Padova, Azienda Ospedaliero-Universitaria Careggi, Firenze

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate leukocyte/myeloid cell-infiltrate in gliomas by using a multimodal PET/MRI imaging technique	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.	24 months