A Phase II Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,075
- 试验地点
- 1
- 主要终点
- To confirm the diagnostic effectiveness of 18F-FDG in patients with known or suspected carcinoma
研究概览
简要总结
Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer Institute has recently been funded to establish a PET centre, and this study will evaluate the effectiveness, value and safety of PET scanning in a number of uncommon cancers in the Canadian health care environment.
详细描述
Background
Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful.
The Cross Cancer Institute has recently been funded to establish a PET centre that will establish a research programme to prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.
Objectives
Primary Objective - The objective of the clinical trial is to establish the general utility and value of 18F-FDG PET imaging in patients with known or suspected myeloma, sarcoma, testicular cancer (seminomatous and non-seminomatous germ cell tumors), endometrial cancer, ovarian cancer, cervical cancer, transitional cell carcinoma of the bladder, renal cell carcinoma, pancreatic, adenocarcinoma, mesothelioma and gastric cancer.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female. (If female of child bearing potential and outside of the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.)
- •Known or suspected primary or metastatic tumours of myeloma, sarcoma, testicular carcinoma (seminomatous and non-seminomatous germ cell tumours), endometrial carcinoma, renal cell carcinoma, pancreatic adenocarcinoma, malignant mesothelioma, gastric carcinoma and cholangiocarcinoma.
- •Age equal to or greater than 15 years
- •Able and willing to follow instructions and comply with the protocol
- •Provide written informed consent prior to participation in this study
- •Karnofsky Performance Scale score 60-100
排除标准
- •Nursing or pregnant females
- •Having had surgery or radiotherapy within 10 days of the planned imaging study
- •Presence of a severe infection
- •Age less than 15 years
- •Blood glucose greater than 10mmol/L
结局指标
主要结局
To confirm the diagnostic effectiveness of 18F-FDG in patients with known or suspected carcinoma
次要结局
- To determine the clinical relevance of PET scans within these patient groups