NCT05267509

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Feb 2022Dec 2026

Study Start

First participant enrolled

February 23, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

February 24, 2022

Last Update Submit

January 22, 2026

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologic confirmation of malignant glioma

You may qualify if:

  • 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:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Florence, Italy

Location

University Hospital

Padua, 325128, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Glioma

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Susanna Mandruzzato, PhD

    Istituto Oncologico Veneto IOV-IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 4, 2022

Study Start

February 23, 2022

Primary Completion

June 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

IT(2)