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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05267509
Other study ID # 2021/27
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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