Quantitative DCE-MRI as a Predictor of Therapeutic Response in Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Shutter-Speed Model
研究概览
简要总结
The purpose of this study is to investigate if a type of magnetic resonance imaging (MRI) scan of the bone marrow before the start of standard chemotherapy can predict complete remission of leukemia patients after the therapy. This type of MRI scan, called dynamic contrast-enhanced MRI (DCE-MRI), measures bone marrow blood flow. For those patients who do not achieve complete remission status after initial therapy and will be treated with additional therapy, the investigators are also interested in determining if the second MRI exam before the additional therapy can predict complete remission. If successfully tested, the MRI exam may be used in the future to help with early identification of patients who are unlikely to respond to standard chemotherapy. This will allow for a personalized therapeutic plan to be developed for these patients at an early stage and prevent them from being exposed to toxic and ineffective therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or relapsed AML patients, who are scheduled to receive standard induction therapy.
- •Age > 8 years and requiring no sedation.
- •Patients must not be pregnant
- •Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to start of study
- •The subject or subject's legal guardian has the ability to understand and the willingness to sign a written informed consent and/or assent document. A signed study-specific informed consent and/or assent must be obtained prior to any study specific procedures.
排除标准
- •Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
- •Patients who have known or suspected allergy to gadolinium-based contrast agent.
- •Severe claustrophobia precluding subject from undergoing a MRI
- •Patients with acute or chronic kidney dysfunction (estimated Glomerular Filtration Rate (eGFR) < 30ml/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease (MDRD) Equation)
- •Pregnant women are excluded from this study because of possible risk to the fetus.
结局指标
主要结局
Shutter-Speed Model
时间窗: Up to 1 year
To explore if Shutter-Speed Model (SSM) dynamic contrast-enhanced MRI (DCE-MRI)of the bone marrow (BM) can predict complete remission (CR) in newly diagnosed or relapsed acute myelogenous leukemia (AML)patients.
次要结局
- Pilot Data(Up to 1 year)
- Complete Response(Up to 1 year)
- Second SSM DCE-MRI(Up to 1 year)
- DCE-MRI Biomarkers(Up to 1 year)
研究者
Wei Huang
Associate Professor
OHSU Knight Cancer Institute