Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan
研究概览
简要总结
Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.
详细描述
Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with "negative" oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known diagnosis of neuroendocrine tumor
- •At least 18 years of age
- •Able to provide informed consent
- •Karnofsky score greater than 50
- •Females of childbearing potential must have a negative pregnancy test at screening/baseline
排除标准
- •Serum creatinine >3.0 mg/dL (270 μM/L)
- •Hepatic enzyme levels more than 5 times upper limit of normal.
- •Known severe allergy or hypersensitivity to IV radiographic contrast.
- •Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
- •Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
- •Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Recognized concurrent active infection
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
结局指标
主要结局
Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan
时间窗: at 1 year
Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).
次要结局
- Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability(at 1 year)
研究者
Ronald C. Walker MD
Professor of Clinical Radiology
Vanderbilt-Ingram Cancer Center