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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT00382252
Study type Interventional
Source Institut Bergonié
Contact
Status Completed
Phase N/A
Start date May 2, 2005
Completion date May 2011

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