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

NCT07447531 | Recruiting DMC

• 1 other identifier: 202504145
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Glioma

Outcome Measures

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.

  Up to 3 months post-radiation therapy

Secondary Outcomes (2)

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

  Up to 3 months post-radiation therapy

• PFS

  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

Study Arms (1)

Diagnostic (T2* MRI, blood sample collection)

EXPERIMENTAL

Patients undergo T2\* MRI over 10 minutes and blood sample collection during radiation therapy simulation, weekly during radiation therapy, and at 1- and 3- months post-radiation therapy in the absence of unacceptable toxicity. Patients also undergo standard MRI throughout the study.

Procedure: T2 (Observed)-Weighted Imaging; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging

Interventions

T2 (Observed)-Weighted Imaging PROCEDURE

Undergo T2\* MRI

Also known as: T2*-Weighted Imaging, T2*MRI, T2*WI

Diagnostic (T2* MRI, blood sample collection)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Diagnostic (T2* MRI, blood sample collection)

Magnetic Resonance Imaging PROCEDURE

Undergo standard MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging

Diagnostic (T2* MRI, blood sample collection)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John M. Buatti: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52245, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• John Buatti, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Buatti, MD

CONTACT

(319) 356-7590; john-buatti@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: October 3, 2025
• Primary Completion (Estimated): October 6, 2028
• Study Completion (Estimated): October 6, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)