Malignant GliomaNCT07447531
T2 Star Magnetic Resonance Imaging and Biomarker Blood Testing to Predict the Change and Progress of Malignant Gliomas
A study testing T2 (Observed)-Weighted Imaging, Biospecimen Collection and Magnetic Resonance Imaging in people with Malignant Glioma, run by John M. Buatti at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- T2 (Observed)-Weighted Imaging, Biospecimen Collection and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 6 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52245
John Buatti, MD, 319-356-7590, john-buatti@uiowa.edu
John Buatti, MD, (319) 356-7590, john-buatti@uiowa.edu
About this study
Official title: Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression
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.
Read the 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.
- Conditions
- Malignant Glioma
- Being tested
- T2 (Observed)-Weighted Imaging, Biospecimen Collection, Magnetic Resonance Imaging
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2 (Observed)-Weighted ImagingProcedure or surgery
Also called T2*-Weighted Imaging, T2*MRI, T2*WI
Undergo T2* MRI
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Undergo blood sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging
Undergo standard MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: T2 (Observed)-Weighted Imaging; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Up to 3 months post-radiation therapy
PFS
Cumulative PFS will be descriptively summarized over time with the method of Kaplan-Meier.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start3 Oct 2025
- Primary completion6 Oct 2028 (estimated)
- Study completion6 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John M. Buatti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John M. Buatti, University of Iowa
- Investigators
- John Buatti, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447531
- Sponsor's protocol ID
- 202504145
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression
- ClinicalTrials.gov ID
- NCT07447531
- Acronym / sponsor ID
- 202504145
- Conditions
- Malignant Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- John M. BuattiUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 6 Oct 2028 (estimated)
- Study completion
- 6 Oct 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (T2* MRI, blood sample collection) | Experimental | Procedure: T2 (Observed)-Weighted Imaging, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2 (Observed)-Weighted ImagingAlso: T2*-Weighted Imaging, T2*MRI, T2*WIUndergo T2* MRI | Procedure or surgery | Diagnostic (T2* MRI, blood sample collection) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Diagnostic (T2* MRI, blood sample collection) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance ImagingUndergo standard MRI | Procedure or surgery | Diagnostic (T2* MRI, blood sample collection) |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Malignant Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Buatti, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2 (Observed)-Weighted Imaging, Biospecimen Collection and Magnetic Resonance Imaging in people with Malignant Glioma, run by John M. Buatti at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Buatti, MD ((319) 356-7590, john-buatti@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.