NCT06659276招募中不适用
Whole Body DWI Sequences As Compared with Standard FDG PET/CT in Patients with Simptomatic Multiple Myeloma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- positivity rate
研究概览
简要总结
The primary objective is to evaluate the concordance of FDG PET/CT and total body DWI MRI sequences performed during staging and at the completion of therapy. Specifically, we will assess the positivity rates, both patient-based and lesion-based (total and by district), of the two methods during staging and at the completion of therapy. An interim analysis will be conducted comparing the two methods, followed by a final prognostic analysis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with symptomatic myeloma in the staging phase or with suspected symptomatic myeloma in the diagnostic phase
- •Patients who have signed the informed consent form
排除标准
- •Patients simultaneously affected by other neoplastic diseases or with a history of other neoplasms in the previous 5 years
- •Age < 18 years
- •Women who are breastfeeding or pregnant
- •Patients with metal implants or devices that constitute an absolute contraindication for MRI
- •Patients with severe claustrophobia
- •Patients with bone pain that prevents prolonged maintenance of the supine position
结局指标
主要结局
positivity rate
时间窗: 33 months
comparison per patient and per lesion between FDG PET CT and WB DWI
次要结局
未报告次要终点
研究者
Cristina Nanni
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究点 (1)
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