[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07447531":3,"trial-entities:NCT07447531":106,"trial-summary:NCT07447531":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":49,"secondary_outcomes":54,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":77,"locations":80,"central_contacts":98,"overall_officials":100,"references":104,"see_also_links":105},"NCT07447531","202504145","T2 Star Magnetic Resonance Imaging and Biomarker Blood Testing to Predict the Change and Progress of Malignant Gliomas","Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression","RECRUITING","2028-10-06","2026-02","2026-03-03","2025-10-03","John M. Buatti","OTHER",true,"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.","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.",[19],"Malignant Glioma",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},15,"ESTIMATED",[29,37,43],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"PROCEDURE","T2 (Observed)-Weighted Imaging","Undergo T2\\* MRI",[34],"Diagnostic (T2* MRI, blood sample collection)",[36],"T2*-Weighted Imaging, T2*MRI, T2*WI",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Biospecimen Collection","Undergo blood sample collection",[34],[42],"Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection",{"type":30,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Magnetic Resonance Imaging","Undergo standard MRI",[34],[48],"Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging",[50],{"measure":51,"description":52,"timeFrame":53},"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",[55,58],{"measure":56,"description":57,"timeFrame":53},"Effects of T2* relaxation and\u002For 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.",{"measure":59,"description":60,"timeFrame":61},"PFS","Cumulative PFS will be descriptively summarized over time with the method of Kaplan-Meier.","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","ALL","21 Years",null,false,{"inclusion":67,"exclusion":72,"raw_text":76},[68,69,70,71],"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",[73,74,75],"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","Inclusion Criteria:\n\n* Age \\> 21 years\n* New pathologically confirmed diagnosis of WHO grade IV malignant glioma\n* KPS \\> 60\n* Ability to give informed consent for standard of care chemotherapy and radiation therapy on the MR Linac and to study procedures for the protocol\n\nExclusion Criteria:\n\n* History of previous malignancy other than non-melanoma skin cancer in the previous 5 years\n* History of iron metabolic disorder such as hemochromatosis\n* Inability to undergo MR studies due to size, claustrophobia, or metal implants or devices",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":95},"University of Iowa Health Care","Iowa City","Iowa","52245","United States",[88,93],{"name":89,"role":90,"phone":91,"email":92},"John Buatti, MD","CONTACT","319-356-7590","john-buatti@uiowa.edu",{"name":89,"role":90,"phone":94,"email":92},"(319) 356-7590",{"lat":96,"lon":97},41.66113,-91.53017,[99],{"name":89,"role":90,"phone":94,"email":92},[101],{"name":89,"affiliation":102,"role":103},"University of Iowa","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":108},[19],[],{"nct_id":4,"found":15,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.","completed","T2 Star MRI and Blood Tests for Malignant Gliomas","This study is looking at whether a special type of MRI called T2 star (T2*) magnetic resonance imaging and blood tests can help predict how malignant gliomas (a type of brain tumor) might change or grow over time. Researchers want to see if these tests can help identify if the tumor is coming back after treatment. You would undergo T2* MRI, standard MRI, and give blood samples. To join, you need to be over 21, have a new diagnosis of a specific type of malignant glioma (WHO grade IV), have a KPS score over 60 (a measure of your ability to perform daily activities), and be able to give informed consent for standard treatments and study procedures. The main goal is to see how T2* MRI relates to a specific marker in your blood up to three months after radiation therapy. The current status of this study is unclear.","The primary endpoint is measured up to 3 months post-radiation therapy.",149,"You would undergo T2* MRI, standard MRI, and provide blood samples. The primary endpoint is measured up to 3 months post-radiation therapy.","Not stated in the trial record.",[44],"v2"]