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

ConditionMalignant Glioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohn M. Buatti

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • T2 (Observed)-Weighted Imaging

    Procedure/Surgery

    Undergo T2\* MRI

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo standard MRI

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Diagnostic (T2* MRI, blood sample collection)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Relationship between T2 (observed)-weighted imaging (T2*) magnetic resonance imaging relation time and dimeric transferrin receptor expression

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

Secondary outcomes

1

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

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
Up to 3 months post-radiation therapy
2

PFS

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John M. Buatti

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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