NCT03779815已完成不适用
A Pilot Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]Florbetaben Positron Emission Tomography for Detecting Amyloidosis in Multiple Myeloma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- sensitivity and specificity per patient analysis
研究概览
简要总结
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic amyloidosis.
详细描述
Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in subjects with multiple myeloma.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is over 19 years old and male or female of any race/ethnicity
- •Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist
- •Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected
- •Subject has voluntarily agreed to participate in the study
排除标准
- •Subject or subject's legally acceptable representative does not provide written informed consent.
- •Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of [18F]Florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
- •Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator.
- •Subject has received any investigational drugs or devices within four weeks prior to the study enrollment.
- •Subject has been previously included in this study.
- •Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
- •Subject is allergic to Florbetaben or any of ingredients of Florbetaben
研究组 & 干预措施
[18F]Florbetaben PET/CT imaging
Experimental
- Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected)
- Intravenous injection of [18F]Florbetaben and PET/CT scanning
- Intervention: Drug ([18F]Florbetaben)
干预措施: [18F]Florbetaben (Drug)
结局指标
主要结局
sensitivity and specificity per patient analysis
时间窗: Up to 6 months after [18F]Florbetaben PET/CT scanning
Sensitivity and specificity of \[18F\]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
次要结局
- sensitivity and specificity per organ analysis(Up to 6 months after [18F]Florbetaben PET/CT scanning)
- Correlation with severity(Up to 6 months after [18F]Florbetaben PET/CT scanning)
- Adverse events(Up to 28 days after [18F]Florbetaben PET/CT scanning)
研究者
Jae-Cheol Jo
Assistant professor
Ulsan University Hospital
研究点 (1)
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