Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Comparison of each method of imaging for detection of tumors
研究概览
简要总结
This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.
详细描述
The purpose of this study is to assess the value of 68Ga-NODAGA-RGD PET/CT for detection of neoangiogenesis at level of neoplastic processes, in patients, compared to 18F-FDG PET/CT (tumors other than glioma) or 18F-FET PET/CT (patients affected by glioma) and to determine the respective diagnostic contribution of every technique.
Every patient will undergo a routine 18F-FDG (or 18F-FET) PET/CT followed by a 68Ga-NODAGA-RGD PET / CT specific for the study within the next 7 days.
(each image procedure duration: 2h)
The criteria of primary evaluation for each of the techniques will be defined:
- On the images of PET/CT: SUVmax, SUVmoyen, VOI ( mL ), SUV41 % ratio [mean SUV of pixels ≥ 41 % of the SUVmax] of lesions / SUV
- On the images of CT: size of the lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield unit (HU)
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
- •Age ≤ 85 years old
- •Karnofsky index: ≥ 80%
- •Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer.
- •Informed consent signed
排除标准
- •Incapacity to sign the informed consent
- •Pregnancy, breastfeeding
- •Age <18 years
研究组 & 干预措施
68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs
Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT
干预措施: 68Ga-NODAGA-RGD PET/CT (Drug)
68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs
Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT
干预措施: 18F-FDG PET/CT (Radiation)
68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs
Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT
干预措施: 18F-FET PET/CT (Radiation)
结局指标
主要结局
Comparison of each method of imaging for detection of tumors
时间窗: within 10 days
To compare the capacity of each of the techniques and their combination to detect tumors, to determine the composition of these tumors (neoangiogenesis, metabolism, necrosis), their extension, the changes due to treatment
次要结局
- ROC analysis and comparison of areas under the curve(Within 10 days)
- Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments(within 10 days)
研究者
John O. Prior
Chief Nuclear Medicine Department
University of Lausanne Hospitals