Role of FDG PET/CT Guided Bone Marrow Biopsy vs. Conventional Bone Marrow Trephine Biopsy for Assessing the Bone Marrow Infiltration in Newly Diagnosed Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy
研究概览
简要总结
Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine.
详细描述
Newly diagnosed patients underwent FDG PET/CT for whole-body staging. All the PET/CT images were analyzed by a qualified nuclear medicine physician. The bone marrow FDG uptake was classified as negative, focal, multifocal and diffuse marrow uptake. A PET/CT guided metabolic bone marrow sampling from the FDG avid marrow-based lesion was done. However, patients with diffuse FDG avidity or no uptake in the marrow differed for PET-guided biopsy. All the patients underwent routine trephine bone marrow sampling. Bone marrow infiltration (final diagnosis) was established based on trephine bone marrow sampling and FDG PET/CT targeted bone marrow biopsy results in the present study. The results of both the biopsies were correlated with the final diagnosis.
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
- •Newly diagnosed cases of lymphoma (both HL and NHL).
- •Hypermetabolic bone marrow lesions on staging 18F-FDG PET/CT, which are accessible for biopsy.
- •Aged between 18 -80 years.
- •Informed consent prior to the procedure.
排除标准
- •Previously treated/relapsed lymphoma.
- •Initiation of therapy (chemotherapy, radiation therapy) and/or hematopoietic growth factor injections before 18F-FDG PET/CT or BMTB.
- •Patients who underwent a prior BMTB to evaluate the role of BMI.
- •Patients with pre-existing bleeding diatheses like hemophilia, coagulopathy, INR > 1.2 and platelet counts < 50,000/mm3,
- •Patients who refuse to provide informed consent.
- •No 18F FDG avid skeletal lesions.
- •Pregnant/Lactating female patients.
- •Non-cooperative patients.
结局指标
主要结局
Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy
时间窗: three months
The final diagnosis of bone marrow infiltration was based on the pathology findings of trephine bone marrow biopsy and FDG PET/CT targeted bone marrow biopsy. The diagnostic accuracy (in percentage) of FDG PET/CT guided metabolic bone marrow biopsy was compared with the accuracy (in percentage) of trephine bone marrow biopsy with respect to final diagnosis.
次要结局
未报告次要终点
研究者
Rajender Kumar
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh