Diagnostic Performance of PET/CT Vs Bone Marrow Biopsy in Exclusion of BM Infiltration for Initial Staging of Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Comparison between PET/CT and BMB in detection of bone marrow involvement
研究概览
简要总结
lymphoma is a common malignancy in the developed world. the two main categories of lymphoma are non-Hodgkin lymphoma and non-Hodgkin lymphoma. Bone marrow biopsy (BMB) is the most direct method of detecting lymphoma infiltration, however it is an invasive procedure. 18 fluro-2deoxy-D glucose PET/CT is a non-invasive examination that can comperhensively evaluate the state of bone marrow (BM) with extremely high sensitivity in detecting bone marrow infiltration of lymphoma.
详细描述
Lymphoma is a common malignancy in the developed world. Many subtypes of lymphomas are known. The two main categories of lymphoma are the non-Hodgkin lymphoma (NHL) (90% of cases) and Hodgkin lymphoma (HL) (10%). Lymphoma makes up 3-4% of all cancers, making them as a group the seventh-most common form.
Bone marrow biopsy is the most direct method of detecting lymphoma infiltration, however, it is an invasive procedure which is accompanied by several complications such as pain, hemorrhage and may miss marrow involvement if infiltration is patchy, or not taken from a part of the marrow that is involved.
18fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is a non-invasive examination that can comprehensively evaluate the state of bone marrow with extremely high sensitivity in detecting bone marrow infiltration of lymphoma and can replace bone marrow biopsy.
At this moment, there is no clear international guideline between the indications of PET-CT and bone marrow biopsy, but there is interest in using the PET/CT findings to either supplement or even replace the BMB in the evaluation of BM involvement in lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial diagnosed patient not receiving treatment.
- •Baseline bone marrow biopsy.
- •Baseline PET/CT.
- •The period between performing PET/CT and bone marrow biopsy is maximum 30 days and without lymphoma treatment between the studies.
排除标准
- •Patient receiving chemotherapy or corticosteroid before doing PET/CT and BMB.
- •patients with known concomitant malignancy.
- •patients who received hemopoietic growth factor injections less than 48 hours before the PET/CT.
- •patients with previously known and treated lymphoma.
结局指标
主要结局
Comparison between PET/CT and BMB in detection of bone marrow involvement
时间窗: 30 days between initial bone marrow biopsy and initial PET/CT before starting treatment for lymphoma
Compare the diagnostic accuracy of PET/CT scan against Bone Marrow Biopsy in detection of bone marrow involvement for staging of lymphoma.
次要结局
未报告次要终点
研究者
Seham Sharef Eid Ahmed
Principle investigator
Assiut University