New Imaging Procedure for the Localisation of Insulinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.
研究概览
简要总结
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.
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
- Single (Outcomes Assessor)
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
- •Biochemically proven endogenous hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm
- •Conventional imaging (CT,MRI or EUS) not older than 2 months
- •Signed written consent
- •Age above 18 years
排除标准
- •Kidney failure (creatinine > 140micromol/l)
- •Known allergies against Exendin-4 (Byetta or Bydureon)
- •Pregnancy
- •Breastfeeding
- •Medication with Byetta or Bydureon
- •Evidence for malignancy (extrapancreatic tumor manifestations)
研究组 & 干预措施
Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
This is a cross-over study comparing three imaging methods (68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT, MRI) in the same patient.
干预措施: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI (Other)
结局指标
主要结局
Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.
时间窗: 4 years
Measuring Tumour to Background Ratio
时间窗: 4 years
次要结局
- Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT, 111 In-DOTA-exendin-4 SPECT/CT and standardized MRI in comparison with conventional imaging (CT,MRI and EUS)(4 years)
- Comparison of the angiogenesis markers with the those of breast carcinoma patients(4 years)
- Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4(4 years)
- Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT(4 years)
- Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT(4 years)