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.
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. OUTLINE: This is a multicenter study. Patients undergo positron emission tomography (PET) and CT scan at baseline. Patients then undergo radiofrequency ablation (RFA) for lung metastases. PET/CT scan is repeated at 1 week, 1 month, and 3 months after RFA. After completion of RFA, patients are followed by clinical examination and conventional scanning at 6, 9, and 12 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
89
Centre Hospitalier de la Cote Basque
Bayonne, France
Institut Bergonie
Bordeaux, France
Hopital Haut Leveque
Pessac, France
Percentage of True Positive Plus True Negative Patients
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).
Time frame: 3 months after RFA
Percentage of True Positive Patients
Sensitivity 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 divided by the number of patients with true positive plus false negative results (sensitivity)
Time frame: 3 months after RFA
Percentage of True Negative Patients
Specificity 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 negative results divided by the number of patients with true negative plus false positive results (specificity)
Time frame: 3 months after RFA
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