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