Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy
研究概览
简要总结
The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow (BM) sampling serves as a window that represents all AML cells distributed throughout the BM, an assumption that has yet to be questioned. Simulation in mice led to inconsistent representation of the full BM, which can incorrectly suggest the absence of leukemic cells. Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the body using for instance a radioactive sugar. In one report, its use in human AML has provided proof-of-principle evidence of unequal distribution of AML cells in BM. Accordingly, the alternative hypothesis is to test if PET scan can demonstrate if BM geography can alter AML cells spread and home them as distinct areas rather than uniform spread as if they are distributed in liquid state.
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
- •New diagnosis of AML according to the WHO (World Health Organization) criteria
排除标准
- •Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease.
- •Acute promyelocytic leukemia (APL).
- •ECOG (Eastern Cooperative Oncology Group) performance status of 3 or more
- •Inadequate renal function (i.e., estimated GFR (glomerular filtration rate) < 60 mL/min/1.73m2).
- •Inadequate hepatic function (i.e., serum bilirubin > 1.5×ULN; AST (aspartate aminotransferase), ALT (alanine aminotransferase) and ALP (alkaline phosphatase) > 2.5×ULN)
- •Presence of uncontrolled systemic fungal, bacterial, viral or other infections (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Having any other severe concurrent disease or serious organ dysfunction that may place the patient at undue risk to receive induction therapy.
- •Pregnancy or lactating female.
研究组 & 干预措施
FDG-PET/CT
(Fluorodeoxyglucose positron-emission tomography) FDG-PET/CT guided bone marrow sampling will be performed at diagnosis and at the end of induction chemotherapy (like cytarabine and daunorubicin). Then, patients will be followed to assess their response, and imaging-guided bone marrow sampling will be repeated in the likely event of disease relapse.
干预措施: FDG-PET/CT guided bone marrow sampling (Procedure)
结局指标
主要结局
Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy
时间窗: Up to 3 years
次要结局
- Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy(Up to 3 years)
研究者
Mohammed Almakadi
MBBS, FRCP(C)
Hamilton Health Sciences Corporation