18F-FAPI PET/MRI Imaging in the Diagnosis and Monitoring of Therapeutic Effect of Myelofibrosis: a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis
研究概览
简要总结
This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.
详细描述
Myelofibrosis (MF) is a pathological process characterized by dysplasia of bone marrow fibrous tissue, clonal proliferation of potential stem cells, inflammatory changes in the bone marrow microenvironment, and extramedullary hematopoiesis. Bone marrow histopathology is the gold standard for diagnosis, but because of the invasive nature of the puncture, repeated examination is not possible to dynamically monitor the disease process. In addition, due to the focal nature of puncture biopsy, it can not accurately reflect the systemic disease. 18F-FDG PET/CT provides visual assessment of MF, but its diagnostic effectiveness decreases as MF progresses. 18F-FAPI PET/MRI characterizes fiber activation processes in a variety of diseases. This study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18F-FDG PET/CT and 18F-FAPI PET/MRI imaging for the evaluation of systemic fibrosis in MF patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.
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
- •Patients with primary myelofibrosis or myelofibrosis secondary to myeloid tumors were diagnosed according to the diagnostic criteria of who
- •Stable vital signs, ECOG score ≥ 2 points, tolerate and cooperate to complete 18F-FDG PET/CT and 18F-FAPI PET/MRI examination.
- •The interval between imaging ,hematologic, cytogenetic and pathology was < 2 weeks.
- •Willing to accept 18F-FDG PET/CT and 18F-FAPI PET/MRI , sign the informed consent.
排除标准
- •Inability or unwillingness to provide informed consent.
- •Other malignancies, autoimmune diseases, or chronic active infections were diagnosed within 1 year before the diagnosis of myelofibrosis.
- •Current infection was present within 1 week before PET examination.
- •Pregnant or lactation.
- •Unable to follow protocol to complete follow-up.
- •Have received glucocorticoid therapy within 2 weeks before PET imaging examination.
- •Using granulocyte colony-stimulating factor (G-CSF) within 4 weeks prior to PET imaging.
结局指标
主要结局
The diagnostic efficiency of 18F-FAPI PET/MRI imaging in myelofibrosis
时间窗: through study completion, an average of 2 years
The diagnostic efficacy of 18F-FAPI PET/MRI in myelofibrosis was evaluated by visual scoring. The pattern of 18F-FAPI accumulation was analyzed on maximum-intensity projection images for each patient, and the extent of 18F-FAPI accumulation was graded on a 5-point scale（0-4） to assess changes in the extent of bone marrow involvement .The higher of the score, maybe the more severe in the myelofibrosis.The changes in diagnostic efficacy of 18F-FAPI PET/MRI imaging in myelofibrosis were compared with the gold standard of bone marrow biopsy by Kappa analysis.
次要结局
- Comparison of clinical prognosis between pathological and 18F-FAPI PET/MRI imaging diagnosis by Kappa analysis.(through study completion, an average of 2 years)