An Integrated Radio-immunological Approach | NCT05267509

Studies
An Integrated Radio-immunological Approach

NCT05267509

Sponsor

Istituto Oncologico Veneto IRCCS

Status

Active, not recruiting

Last Update Posted

Jan 23, 2026Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Glioma, Malignant

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2022Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 24, 2022

First Submission Date that Met QC Criteria

Feb 24, 2022

First Posted Date

Mar 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 23, 2026Actual

Name	Class
Azienda Ospedaliero-Universitaria Careggi	OTHER
Azienda Ospedaliera di Padova	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

31Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with histologic confirmation of malignant glioma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanna Mandruzzato, PhD	Istituto Oncologico Veneto IOV-IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Florence			Italy
University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided