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NCT Number: NCT07447531

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T2 (Observed)-Weighted Imaging

Procedure

Undergo T2* MRI

Other names: T2*-Weighted Imaging, T2*MRI, T2*WI

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Magnetic Resonance Imaging

Procedure

Undergo standard MRI

Other names: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging

Primary outcomes

  1. 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

    Will be characterized with mixed effects regression modeling. Correlation between the two biomarkers will be estimated with the multivariate linear mixed effects regression approach of Hamlett, Ryan, and Wolfinger. Cluster bootstrapping will be employed to calculate a 95% confidence interval for their correlation and a p-value for testing its significance at the 5% level.

Secondary outcomes

  1. Effects of T2* relaxation and/or circulating dimeric transferrin receptor on progression-free survival (PFS)

    Time frame: Up to 3 months post-radiation therapy

    Cox regression will be used to model the univariable and multivariable effects of T2* relaxation time and dimeric transferrin receptor on PFS. Time-dependent receiver operating characteristic (ROC) analysis will be performed to estimate ROC curves at 6-months and areas under the curves (AUCs) as measures of prognostic performances. AUCs will be compared to help determine whether the combination of biomarkers is more prognostic than either biomarker alone. Sensitivities and specificities from the ROC curves will also be reported across the observed range of biomarkers (cutoff) values to further characterize their performance in predicting PFS.

  2. 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

    Cumulative PFS will be descriptively summarized over time with the method of Kaplan-Meier.

Study contacts

Contact information is provided by the study sponsor or research team.

John Buatti, MD

CONTACT

[email protected]

(319) 356-7590

Sponsors and collaborators

Lead sponsor

John M. Buatti

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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