Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- validate the PRESCIENT criteria
研究概览
简要总结
People with neuroendocrine cancer typically have imaging scans before and after treatment, including positron emission tomography (PET) scans. The scans are analyzed using a set of criteria that describes how the disease has responded to treatment. The purpose of this study is to establish new criteria for doctors to use when evaluating these PET scans. Researchers are testing whether these new criteria are useful for predicting whether a person's cancer gets better, gets worse, or stays the same. Researchers will also compare these new criteria to the current standard criteria for evaluating imaging scans.
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
- •Subjects affected by histologically proven, somatostatin-receptor positive, metastatic or inoperable well-differentiated G1, G2 or G3 neuroendocrine tumors (NETs) candidate to receive PRRT with 177Lu-DOTATATE per standard of care.
- •Inclusion Criteria:
- •Histologically proven or cytologically confirmed, metastatic or inoperable NETs
- •Measurable disease as defined by RECIST 1.
- •Overexpression of somatostatin receptors of the target lesions at somatostatin receptor imaging (68Ga-DOTATATE or 64Cu-DOTATATE PET/CT) with SUV of lesions greater than normal liver at least in 1 metastasis.
排除标准
- •Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
- •Presence of somatostatin receptor negative lesions.
研究组 & 干预措施
People With Neuroendocrine Tumors having a PET/CT or MRI
This is a non-interventional observational study of imaging.
干预措施: positron emission tomography (PET) scans (Diagnostic Test)
结局指标
主要结局
validate the PRESCIENT criteria
时间窗: 1 year
On this prospective validation cohort, the prognostic value of each criteria for the 1-year PFS will be assessed, using a Cox regression model (stratified on the site) and the area under the receiver operating curve (AUC) for time-dependent outcome using inverse probability of censoring weighting.
次要结局
未报告次要终点