PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Incidence of extramedullary myeloid leukemia (EML)
研究概览
简要总结
This pilot phase I trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI), fludeoxyglucose F-18 (18F-FDG) PET/computed tomography (CT), and whole body MRI work in finding extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia. Extramedullary myeloid leukemia is a type of cancer found outside of the bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone marrow aspirations. Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the incidence of extramedullary myeloid leukemia (EML) in patients with newly diagnosed acute myeloid leukemia (AML), including acute promyelocytic leukemia (APL), by imaging criteria using PET/MR (magnetic resonance), whole body MR, and PET/CT.
SECONDARY OBJECTIVES:
I. To qualitatively and quantitatively assess PET/MR and PET/CR that will be performed with and without fiducial markers, and to correlate these findings with clinical outcomes of treatment response, relapse, and patterns of relapse.
II. Correlate findings of EML as in the primary objectives with clinical outcomes of treatment response, relapse, and patterns of relapse including location of relapse compared to site of EML.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed AML
- •Non-English speaking subjects will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking subjects.
排除标准
- •Patients with contraindications to MR
- •Patients with a known allergy to MR contrast agents
- •Uncontrollable claustrophobia
- •Recipients of more than minimal anti-leukemia treatment, with minimal treatment defined as: leukapheresis, hydroxyurea, or Cytarabine more than 1 g per square meter.
- •Patients with secondary or relapsed AML or APL should be excluded.
- •Patients with known extramedullary leukemia
- •Positive pregnancy test in a female of childbearing potential
- •Younger than 18 years
- •Greater than 400 pounds in weight
- •Patients with uncontrolled diabetes
- •Cognitive impaired adults or prisoners will be excluded
- •Estimated glomerular filtration rate (eGFR <30) will be excluded
研究组 & 干预措施
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Gadolinium (Drug)
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Three-Dimensional Spoiled Gradient MRI (Procedure)
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Diffusion Weighted Imaging (Procedure)
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Fludeoxyglucose F-18 (Radiation)
Diagnostic (18F-FDG PET/CT, whole body PET/MRI)
Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Incidence of extramedullary myeloid leukemia (EML)
时间窗: At time of imaging
Defined as increased fludeoxyglucose F-18 uptake on positron emission tomography (PET)/computed tomography and increased signal on T2 weighted imaging or diffusion weighted imaging and enhancement in soft tissue on whole body PET/magnetic resonance imaging. Estimates and 95% confidence intervals for the incidence of EML will be reported for each imaging modality based on the exact Clopper-Pearson method.
次要结局
未报告次要终点