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IMMUNO-IMAGING: An Integrated Radio-immunological Approach

Sponsor
Istituto Oncologico Veneto IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05267509
Collaborator
Azienda Ospedaliero-Universitaria Careggi, Firenze (Other), Azienda Ospedaliera di Padova (Other)
90
Enrollment
2
Locations
35.3
Anticipated Duration (Months)
45
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of the Immuno Suppressive Characteristics of Glioma Patients by an Integrated Radio-immunological Approach
    Actual Study Start Date :
    Feb 23, 2022
    Anticipated Primary Completion Date :
    Jan 31, 2024
    Anticipated Study Completion Date :
    Jan 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Florence Italy
    2 University Hospital Padova Italy 325128

    Sponsors and Collaborators

    • Istituto Oncologico Veneto IRCCS
    • Azienda Ospedaliero-Universitaria Careggi, Firenze
    • Azienda Ospedaliera di Padova

    Investigators

    • Principal Investigator: Susanna Mandruzzato, PhD, Istituto Oncologico Veneto IOV-IRCCS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Oncologico Veneto IRCCS
    ClinicalTrials.gov Identifier:
    NCT05267509
    Other Study ID Numbers:
    • 2021/27
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glioma

    Study Results

    No Results Posted as of Mar 24, 2022