A Phase II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- demonstrate the safety of FDG-PET by documentation of adverse events
研究概览
简要总结
18F-fluorodeoxyglucose (18F-FDG) has been approved by many regulatory agencies world-wide and is in widespread use in the United States, Japan and Europe. In the United States, 18F-FDG scanning in oncology is approved for federal healthcare reimbursement for non-Hodgkin's lymphoma, Hodgkin's disease, colorectal cancer, lung cancer, oesophageal cancer, melanoma, head and neck cancer and breast cancer. 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 imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. Current literature suggests that functional imaging with 18F-FDG Positron Emission Tomography (PET) may play an important role in the imaging evaluation of patients with soft tissue sarcoma, including guiding biopsy; detecting local recurrence at sites of tumour resection; detecting metastatic disease; predicting and monitoring response to therapy; and assessing for prognosis. In appropriate situations, it is possibly the most effective diagnostic strategy. However, due to the low incidence of these tumours, prospective studies with large multicenter patient groups will be essential to define the exact diagnostic role of 18F-FDG PET in this clinical setting.
详细描述
Background: Positron Emission Tomography (PET) is a specialized nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these tracers, 18F-2-fluoro-2-deoxyglucose (FGD), an analog of glucose, is used to determine abnormal glucose metabolism in tumours and other sites. FDG has general applications where abnormal glucose metabolism may be present such as differentiating tumour from scar tissue, evaluating the presence of tumour in light of rising tumour markers and normal morphological imaging, and assessing response to therapy.
The Cross Cancer Institute has been funded to establish a PET centre and research program 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. A cyclotron has been installed at the Cross Cancer Institute which produces 18F-fluoride that is used in the automated synthesis of FDG. The three PET scanners in the Department of Oncologic Imaging will be used for this protocol.
Objectives:
Primary - establish the general utility and value of FDG-PET imaging in patients with known or suspected soft tissue sarcoma.
Secondary - demonstrate the safety of FDG-PET imaging by documentation of adverse events; determine whether the number of subjects available for study at the Cross Cancer Institute is sufficient to achieve statistically significant results; determine the feasibility of extending this study to a larger multicenter design.
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 soft tissue sarcoma
- •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
- •Age less than 15 years
- •A history of malignancy other than soft-tissue sarcoma (excluding basal cell carcinoma and cervical intraepithelial neoplasia)
- •Recruitment: Study subjects will be referred to the Cross Cancer Oncologic Imaging Department by their physicians. The patient's study eligibility will be confirmed during the booking telephone call and eligible, interested patients will be scheduled for a PET scan.
结局指标
主要结局
demonstrate the safety of FDG-PET by documentation of adverse events
establish the general utility, value and clinical relevance of FDG-PET imaging in patients with known or suspected soft tissue sarcoma
次要结局
- determine whether the number of subjects available for study at the Cross Cancer Institute (CCI) is sufficient to achieve statistically significant results
- determine the feasibility of extending this study to a larger multicenter design