PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Metastatic Cancer

• Registration Number: NCT00382252
• Lead Sponsor: Institut Bergonié

Brief 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.

Detailed 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 Timeline

• Study Start: 2005-05-02
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• Primary Completion: 2009-12
• Study Completion: 2011-05
• Results First Submitted: 2021-12-17
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Results First Posted: 2022-03-09
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of True Positive Plus True Negative Patients	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of True Positive Patients	3 months after RFA	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)
Percentage of True Negative Patients	3 months after RFA	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)

Trial Locations

Locations (3)

Centre Hospitalier de la Cote Basque; 🇫🇷 Bayonne, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Hopital Haut Leveque; 🇫🇷 Pessac, France