2024-516156-18-00招募中2 期
Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients with Neuroendocrine Neoplasms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS).
研究概览
简要总结
To develop models based on tumor measurements derived from combined 18FDG and 64Cu-DOTATATE PET/CT scans to predict progression-free survival for patients with neuroendocrine neoplasms.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age above or of 18 years
- •Histopathologically verified gastro-pancreatic neuroendocrine neoplasm (GEP-NEN: GEP NET G1-G3 or GEP-NEC) or unknown primary tumor with NEN-positive metastases suggesting GEP origin on pathology examination.
- •Must be able to read and understand the patient information in Danish and to give informed consent.
- •WHO Performance status 0-2.
排除标准
- •Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach
- •History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18FDG or 64Cu-DOTATATE
- •Breast-feeding
- •Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
- •Uncontrolled diabetes
- •Uncontrolled infection
- •Exacerbation in autoimmune diseases
- •Other active cancer disease
- •Conditions or diseases (e.g. uncontrolled Parkinson’s disease) making the patient unable to lie still in the scanner
- •Severe claustrophobia
结局指标
主要结局
Progression free survival (PFS).
Progression free survival (PFS).
次要结局
- Overall survival (OS)
- The proportion of patients who are considered eligible for peptide receptor radionuclide therapy based on their 64Cu-DOTATATE PET/CT scan
- The correlation between standardized uptake values from tumors and healthy tissues derived from manually depicted regions-of-interests measured on 18FDG and 64Cu-DOTATATE
研究者
Mathias Loft
Scientific
Rigshospitalet
研究点 (1)
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