Ga-68-CXCR4 PET/CT in Detecting, Evaluating Response to Treatment, and Monitoring Risk of Aggressiveness of Indolent B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma
研究概览
简要总结
This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing treatment response, and monitoring the risk of aggressiveness in indolent B-cell lymphoma. The background introduces CXCR4 and discusses its role in cancer research. Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising detection capabilities across various lymphomas, suggesting its potential as a superior imaging modality for low-grade lymphomas.
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
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The pathological diagnosis is slow-growing lymphoma, such as: marginal-zone B-cell lymphoma, Waldenstrom macroglobulinemia lymphocytic lymphoma, CLL/SLL, mantle cell lymphoma.
- •Have undergone or planned to undergo FDG PET scan for indications including initial staging, therapeutic response evaluation, or follow-up examinations within 3 to 6 months in the clinical observation group.
- •Able to lie flat for at least 30 minutes.
- •Signing the subject consent form.
- •ECOG grade 0-
- •The timing of F-18-FDG usage in this trial follows the "Lymphoma Treatment Principles" of our institution.
排除标准
- •Pregnant woman
- •Severe renal impairment (eGRF< 30ml/min)
- •Known or suspected allergy to radiopharmaceuticals
- •Concurrent or previous diagnosis of malignancies other than lymphoma
- •Inability to undergo the necessary PET scan procedure
- •Refusal or unwillingness to sign the informed consent form
- •Severe medical conditions (severe disabilities, mental disorders)
研究组 & 干预措施
Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
Indolent B-cell Lymphoma such as marginal-zone B-cell lymphoma、Waldenstrom macroglobulinemia lymphocytic lymphoma、CLL/SLL、mantle cell lymphoma.
干预措施: Ga-68-CXCR4 (Drug)
结局指标
主要结局
Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma
时间窗: up to 24 months
Detection rate = number of positive scan / total number of scan Sensitivity = number of true positive scan / total number of proven recurrent patient Specificity = number of true negative scan / total number of proven free of disease patient Accuracy = number of (true positive scan + true negative scan) / total number of scan Positive predictive value = number of true positive scan / number of positive scan Negative predictive value = number of true negative scan / number of negative scan
次要结局
- Prognostic value of Ga-68-CXCR4 PET/CT scan(up to 36 months)
- Ga-68-CXCR4 compared to F-18-FDG PET/CT(up to 24 months)
- Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT(up to 24 months)