PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases
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.
|Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Procedure: computed tomography Procedure: positron emission tomography Procedure: radiofrequency ablation|
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases|
- Accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA)
- Sensitivity, specificity, false-positive rate, and false-negative rate of PET/CT scan
- Morbidity associated with RFA
- Overall survival
|Study Start Date:||September 2005|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382252
|Centre Hospitalier de la Cote Basque|
|Bayonne, France, 64100|
|Bordeaux, France, 33076|
|Hopital Haut Leveque|
|Pessac, France, 33604|
|Study Chair:||Francoise Bonichon, MD||Institut Bergonié|