Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between FDG-PET and tumor biology
研究概览
简要总结
The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥18 years
- •Informed consent
- •WHO performance status ≤2
- •Progressive disease (as defined by the local investigator) or newly diagnosed disease (defined as prior to medical or oncological intervention except for somatostatin analogue treatment).
- •Pathology confirmed diagnosis of pancreatic or duodenal neuroendocrine tumour WHO G1-G
- •o Exception: In newly diagnosed patients with high suspicion of PNET based on clinical and radiological parameters where tissue sample have not yet been obtained. These patients may be included and subsequently excluded if pathology cannot confirm NET.
- •Biopsy procedure not associated with inappropriate risk as determined by the responsible physician.
排除标准
- •Patient does not consent
- •Permanent risk factors for biopsy
- •Long term treatment with anticoagulant that cannot be temporarily paused without unacceptable risk.
- •Permanent coagulation disorder
- •Pregnancy or no contraceptive in fertile women.
结局指标
主要结局
Correlation between FDG-PET and tumor biology
时间窗: Through study completion, an average of 3 years.
18F-FDG-PET SUVmax correlation to Ki67 index (determined as percentage of tumor cells with positive Ki67 imunohistochemical staining).
次要结局
未报告次要终点
研究者
Barbro Eriksson
Professor, Senior Attending
Uppsala University