The Efficiency of 18F-FDG PET Probe Signal in Bone Marrow for Predicting Acute Myeloid Leukemia Patients' Response to Induction Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Composite complete remission rate (CRc)
研究概览
简要总结
The purpose of this study is to evaluate the predictive value of 18F-FDG PET probe signal in de novo diagnosed or refractory/relapsed patients with acute myeloid leukemia. It is hypothesized that the intensity of 18F-FDG signal, an indicator of glucose uptake capacity, in various cell subsets of bone marrow will improve the predictive effect of clinical standard prognostic work-up.
详细描述
Rationale:
FDG is incorporated by leukemia cells and other cell subsets in bone marrow micro-environment of various degree. The heterogeneous FDG uptake is a promising marker for predicting response to treatment. The investigators will collect bone marrow under standard clinical work-up after 18F-FDG PET/CT scan and correlate the FDG signal intensity with clinical and genomics features of the patients to explore its prognostic significance.
Objective
The primary objective of this research project is to investigate the intensity of FDG PET probe based glucose uptake signal in predicting induction treatment response of AML. As secondary objectives, this analysis will be applied to calculate the overall predictive specificity and sensitivity of FDG probe avidity in predicting PFS and OS.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Acute myeloid leukemia, non APL
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Patients voluntarily participated in this study and signed the informed consent
排除标准
- •Uncontrolled systemic diseases (such as diabetes, non controlled heart failure, etc.)
结局指标
主要结局
Composite complete remission rate (CRc)
时间窗: At the end of Cycle 2 (each cycle is about 28 days)
Partial response (PR) + complete response (CR) rate
次要结局
- Progress-free survival (PFS )(From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Hui Zeng
Director of Hematology Department of the First Affiliated Hospital of Jinan University
First Affiliated Hospital of Jinan University