University of Iowa Health Care
Iowa City, Iowa, 52245, United States
Location status: Recruiting
Location contact
John Buatti, MD
CONTACT
John Buatti, MD
CONTACT
NCT Number: NCT07447531
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52245, United States
Location status: Recruiting
John Buatti, MD
CONTACT
John Buatti, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo T2* MRI
Other names: T2*-Weighted Imaging, T2*MRI, T2*WI
Undergo blood sample collection
Other names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
John M. Buatti
Other
Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression
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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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