Evaluating Iron-Dependent Biomarkers of Malignant Glioma (WHO Grade IV) Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Relationship between T2 (observed)-weighted imaging (T2*) magnetic resonance imaging relation time and dimeric transferrin receptor expression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Diagnostic (T2* MRI, blood sample collection)
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.
干预措施: T2 (Observed)-Weighted Imaging (Procedure)
Diagnostic (T2* MRI, blood sample collection)
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.
干预措施: Biospecimen Collection (Procedure)
Diagnostic (T2* MRI, blood sample collection)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Relationship between T2 (observed)-weighted imaging (T2*) magnetic resonance imaging relation time and dimeric transferrin receptor expression
时间窗: 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.
次要结局
- 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)
研究者
John M. Buatti
Professor
University of Iowa