68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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 novel scanning method that may have improved sensitivity and resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will be imaged with this agent and it will be compared to conventional imaging methods to determine the safety and efficacy of this radiopharmaceutical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated
- •At least 18 years of age
- •Able to provide informed consent
- •Karnofsky performance score greater than 50
- •Females of childbearing potential must have a negative pregnancy test at screening/baseline
排除标准
- •Serum creatinine > 2.0 mg/dL
- •Hepatic enzyme levels more than 3 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 standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Recognized concurrent active infection
- •Previous systemic or radiation treatment for another cancer of any type within the last 2 years
- •Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
研究组 & 干预措施
Scan
We will perform 68Ga-DOTATATE PET scans on subjects.
干预措施: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 5 years
次要结局
- Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques(5 years)
- We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)(5 years)
研究者
Richard J. Campeau, M.D., FACNM
Professor of Radiology and Internal Medicine
Ochsner Health System