NCT01967537已完成2 期
Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan
研究概览
简要总结
Background:
- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs.
Objectives:
- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas.
Eligibility:
- Adults over 10 years old with a suspected NET or family history of NET.
Design:
- Participants will be screened with a medical history and physical exam, and have a blood test.
- Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images.
- A standard computed tomography (CT) scan of the chest, abdomen, and pelvis.
- An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT.
- A 68Gallium-DOTATATE positron emission tomography (PET)/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes.
- Researchers will compare images from the three scans.
- Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.
详细描述
Background:
- Neuroendocrine tumors (NETs) are rare malignancies occurring in the gastrointestinal tract, islets of the pancreas, lung, adrenal medulla and thyroid C-cells.
- Their incidence has increased over the last decade, with an incidence of 6 per 100,000 persons a year and they represent 0.46% of all malignancies.
- Most NETs are sporadic, but they can be part of familial cancer syndromes such as multiple endocrine neoplasia type 1 (MEN1), MEN2, and neurofibromatosis type 1 (NF1) or Von Hippel-Lindau (VHL) syndrome.
- Surgical resection remains the only curative treatment option for patients with NETs but 80% of patients are diagnosed with advanced (metastatic, locally inoperable, or recurrent) disease.
- The main prognostic factor in patients with NET is the extent of disease.
- The best imaging technique for detecting unknown primary and metastatic NETs has yet to be determined.
- NET cells express somatostatin receptors that can be targeted with radiolabeled 68Gallium-DOTATATE (Octreotate) for imaging purposes.
- The primary goal of this protocol is to determine the accuracy of a new somatostatin receptor targeted imaging technique, using 68Gallium-DOTATATE PET/CT to detect unknown primary and metastatic NETs.
Objectives:
-To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary and metastatic gastrointestinal and pancreatic neuroendocrine tumors.
Eligibility:
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
- None
入排标准
- 年龄范围
- 10 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
68Gallium DOTATATE imaging
Experimental
68Gallium DOTATATE imaging
干预措施: 68Gallium DOTATATE (Drug)
68Gallium DOTATATE imaging
Experimental
68Gallium DOTATATE imaging
干预措施: Radio-guided surgery (Procedure)
结局指标
主要结局
Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan
时间窗: During PET Scan, up to 2 hours annually for up to 5 years
Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.
次要结局
- Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan(During radioguided surgery, up to 2 hours)
- Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor(During radioguided surgery, up to 2 hours)
- Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2(During PET Scan, up to 2 hours annually)
- The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE(Radio-guided surgery, up to 2 hours)
- Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)(Date treatment consent signed to date off study, approximately 50 months and 17 days.)
研究者
Naris Nilubol, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (1)
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