Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
研究概览
简要总结
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female ≥ 18 years old
- •Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
- •Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors >1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors >1cm).
排除标准
- •Participants with well-differentiated neuroendocrine tumors
- •Participants who have undergone 68Ga-dotatate PET scan in the past
- •Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.
研究组 & 干预措施
Participants receiving PET scan
Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract
干预措施: 68Ga-DOTATATE (Drug)
Participants receiving PET scan
Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract
干预措施: Positron Emission Tomography (PET) Scan (Diagnostic Test)
结局指标
主要结局
Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
时间窗: Up to 10 months
Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake \> liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
次要结局
- Percentage of Participants with No Uptake to Very High Uptake on PET(Up to 10 months)