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Recruiting NCT07447531

T2 Star Magnetic Resonance Imaging and Biomarker Blood Testing to Predict the Change and Progress of Malignant Gliomas

No phase Interventional Malignant Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T2 (Observed)-Weighted Imaging, Biospecimen Collection, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Malignant Glioma. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression

Overview

This clinical trial studies whether T2 star (T2\*) magnetic resonance imaging (MRI) and biomarker blood testing can help predict how World Health Organization (WHO) grade IV gliomas (malignant gliomas) might change or progress over time.

Detailed description

This clinical trial studies whether T2 star (T2\*) magnetic resonance imaging (MRI) and biomarker blood testing can help predict how World Health Organization (WHO) grade IV gliomas (malignant gliomas) might change or progress over time. WHO grade IV gliomas are the most common primary brain tumors. Despite aggressive standard of care treatment, overall survival remains low. Early identification of whether the glioma comes back after a period of improvement (recurrence) remains an important part of treatment management. Early identification of recurrence can be complicated as treatment effects can cause inflammation, making it difficult to identify recurrence on standard MRI. It has been shown that WHO grade IV gliomas have increased iron content and that as the glioma is treated, markers in the blood that represent iron related cell death (biomarkers) increase. T2\* mapping is an MRI technique routinely used to assess iron content within tissues and may help identify recurrence of the glioma on the MRI. The biomarker blood test in this study checks the levels of iron-related cell death biomarkers in the blood, which may help predict how well patients are responding to treatment. T2\* MRI and biomarker blood testing may be an effective way to predict how malignant gliomas might change or progress over time.

Interventions

  • Procedure T2 (Observed)-Weighted Imaging
    Undergo T2\* MRI
  • Procedure Biospecimen Collection
    Undergo blood sample collection
  • Procedure Magnetic Resonance Imaging
    Undergo standard MRI

Primary outcome measures

  • Relationship between T2 (observed)-weighted imaging (T2*) magnetic resonance imaging relation time and dimeric transferrin receptor expression [Time frame: Up to 3 months post-radiation therapy]
Secondary outcome measures (2)
  • Effects of T2* relaxation and/or circulating dimeric transferrin receptor on progression-free survival (PFS) [Time frame: Up to 3 months post-radiation therapy]
  • PFS [Time frame: From treatment initiation to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, assessed up to 3 months post-radiation therapy]

Eligibility criteria

Inclusion criteria

  • Age > 21 years
  • New pathologically confirmed diagnosis of WHO grade IV malignant glioma
  • KPS > 60
  • Ability to give informed consent for standard of care chemotherapy and radiation therapy on the MR Linac and to study procedures for the protocol

Exclusion criteria

  • History of previous malignancy other than non-melanoma skin cancer in the previous 5 years
  • History of iron metabolic disorder such as hemochromatosis
  • Inability to undergo MR studies due to size, claustrophobia, or metal implants or devices

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Iowa Health Care — Iowa City

Identifiers

NCT: NCT07447531 · 202504145

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗