68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Uptake detected by investigational imaging agent
研究概览
简要总结
This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.
详细描述
The purpose of this research study is to evaluate a PET tracer (68Ga-Citrate) that can localize the origin of patients diagnosed with fever of unknown origin (FUO) using a PET/MRI scanner. We hope to learn if this can detect FUO better than with the present nuclear imaging standard of care (67Ga SPECT).
We propose the following aim:
• To evaluate 68Ga Citrate PET/MRI for detection of origin of fever in patients with fever of unknown origin.
Patients disgnosed with fever of unknown origin are injected intravenously (IV) with 370 MBq of 68Ga Citrate. 45-60 minutes later, a whole body PET/MRI images are obtained.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is >/=18 years old at the time of the scan.
- •Patient with diagnosis of FUO.
- •Patient is capable of complying with study procedures.
- •Patient can remain still for duration of imaging procedure.
- •Able to provide written consent.
排除标准
- •Patient is pregnant or nursing.
- •Metallic implants (contraindicated for MRI).
- •History of renal insufficiency (only for MRI contrast administration).
- •Inability to lie still for the entire imaging time.
- •Inability to complete the needed investigational and standard of care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
- •Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
研究组 & 干预措施
Diagnostic 68Ga-Citrate PET/MRI Imaging
Participants will receive separate scans, first a SPECT scan following administration of the 67Ga Citrate tracer (standard of care), then a PET/MRI scan following administration of the 68Ga-Citrate tracer (investigational); some participants will also receive IV gadolinium-based contrast injection. Scans will be performed 45-60 minutes following injection of the tracer.
干预措施: 68Ga-Citrate PET/MRI (Drug)
Diagnostic 68Ga-Citrate PET/MRI Imaging
Participants will receive separate scans, first a SPECT scan following administration of the 67Ga Citrate tracer (standard of care), then a PET/MRI scan following administration of the 68Ga-Citrate tracer (investigational); some participants will also receive IV gadolinium-based contrast injection. Scans will be performed 45-60 minutes following injection of the tracer.
干预措施: 67Ga-Citrate SPECT (Drug)
Diagnostic 68Ga-Citrate PET/MRI Imaging
Participants will receive separate scans, first a SPECT scan following administration of the 67Ga Citrate tracer (standard of care), then a PET/MRI scan following administration of the 68Ga-Citrate tracer (investigational); some participants will also receive IV gadolinium-based contrast injection. Scans will be performed 45-60 minutes following injection of the tracer.
干预措施: Positron Emission Tomography (Device)
Diagnostic 68Ga-Citrate PET/MRI Imaging
Participants will receive separate scans, first a SPECT scan following administration of the 67Ga Citrate tracer (standard of care), then a PET/MRI scan following administration of the 68Ga-Citrate tracer (investigational); some participants will also receive IV gadolinium-based contrast injection. Scans will be performed 45-60 minutes following injection of the tracer.
干预措施: Magnetic Resonance Imaging (Device)
Diagnostic 68Ga-Citrate PET/MRI Imaging
Participants will receive separate scans, first a SPECT scan following administration of the 67Ga Citrate tracer (standard of care), then a PET/MRI scan following administration of the 68Ga-Citrate tracer (investigational); some participants will also receive IV gadolinium-based contrast injection. Scans will be performed 45-60 minutes following injection of the tracer.
干预措施: SPECT (Device)
结局指标
主要结局
Uptake detected by investigational imaging agent
时间窗: Up to 12 months
The uptake detected on 68Ga Citrate PET/MRI and conventional 67Ga Citrate SPECT will be compared. Outcome will be reported as infectious uptake detected per patient for each imaging method.
次要结局
未报告次要终点
研究者
Carina Mari Aparici
Clinical Professor, Radiology/ Nuclear Medicine
Stanford University