Per-operating Use of a Probe for Detection of β+
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions
研究概览
简要总结
The objective of the study is to evaluate the sensibility of the probe Forimtech to detect β+ emission in vivo in humans and its usefulness during elective surgical procedure Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive surgery or complement of resection of tumors.
The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by the 18F-FDG.PET/CT
详细描述
Patients with a malignant neoplasic lesion known or suspected for which a surgery is planned will be presented with the protocol. If inclusion/exclusion criteria are fulfilled all the procedures will be planned. A 18F-FDG PET/CT will be done. Surgery will be conducted within 3 hours after the I.V. injection of 18F-FDG according to the standard procedure applied in the visceral surgery department. During the surgery, emission of β+ from the lesion (s) seen during the PET/CT will be detected with the probe.
Resected pieces will be analysed histologically.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 80 years old;
- •Karnofsky index ≥80% ;
- •Informed consent signed
- •Patients with an indication of thoracic, visceral, or ENT surgery with the aim of a diagnostic biopsy, of an invasive minimal treatment, or an initial or complementary resection
排除标准
- •Pregnancy
- •Enable to sign informed consent
研究组 & 干预措施
18F-FDG PET/CT
18F-FDG radiotracer All patients will undergo a 18F-FDG PET/CT and a surgery with probe detection of β+''
干预措施: 18F-FDG PET/CT (Radiation)
结局指标
主要结局
Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions
时间窗: day 0
Topography and intensity of detection by the probe of emission of β+ by the lesion(s) • Intensity of emission of β+ by the non specific background and the adjacent structures
次要结局
- PET/CT imaging results(day 0)
- .Comparison of AUC of the imaging methods(within 10 days after study procedure)
- Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions(within 10 days after study procedure)
研究者
John O. Prior
Chief of Nuclear Medicine Department
University of Lausanne Hospitals