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.
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) [ Designated as safety issue: No ]
- Sensitivity, specificity, false-positive rate, and false-negative rate of PET/CT scan [ Designated as safety issue: No ]
- Morbidity associated with RFA [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|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|