Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 3
- 主要终点
- Percentage of True Positive Plus True Negative Patients
研究概览
简要总结
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the patient's response to treatment.
PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in evaluating response to treatment in patients undergoing radiofrequency ablation for lung metastases.
详细描述
OBJECTIVES:
Primary
- Determine the accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA) in patients with lung metastases.
Secondary
- Determine the agreement between observers analyzing PET/CT scan results.
- Determine the outcome of these patients.
- Determine the false-positive rate and false-negative rate of PET/CT scan at 1 and 3 months in these patients.
- Determine the optimal time for obtaining a negative PET scan.
- Determine the sensitivity, specificity, positive predictive value, and negative predictive value of PET/CT scan at 1 and 3 months.
- Determine the morbidity associated with RFA.
- Determine the disease-free survival after RFA and the factors predicting recurrent disease in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cancer
- •Radiologically suspected pulmonary metastases
- •May be confirmed histologically or by specific markers
- •Less than 6 lesions
- •Lesions < 40 mm
- •Prior positron emission tomography shows 1 hyperfixation (standard uptake variable > 3) at the level of lesions to be treated
- •Lesions must not be attached to or next to major mediastinal structures
- •Radiofrequency ablation planned as treatment
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 6 months
- •No uncontrolled medical condition, including any of the following:
- •Psychiatric condition
- •Infection
- •Coronary insufficiency
- •New York Heart Association class III-IV heart disease
- •No other serious condition
- •No contraindication to general anesthesia
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •At least 30 days since prior participation in an investigational study
- •At least 30 days since prior chemotherapy
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
18F-FDG PET/CT + RFA
18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.
RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.
CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.
干预措施: computed tomography (Procedure)
18F-FDG PET/CT + RFA
18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.
RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.
CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.
干预措施: positron emission tomography (Procedure)
18F-FDG PET/CT + RFA
18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.
RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.
CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
Percentage of True Positive Plus True Negative Patients
时间窗: 3 months after RFA
Accuracy of PET/CT scan to determine response of patients at 3 months will be assessed and compared with standard biopsy 3 months after RFA ,if performed or follow-up at 12 months. Number of patients with true positive results plus number of patients with true negative results divided by the number of evaluable patients (accuracy).
次要结局
- Percentage of True Positive Patients(3 months after RFA)
- Percentage of True Negative Patients(3 months after RFA)