Clinical Trials Directory

Trials / Completed

CompletedNCT00382252

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

Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Institut Bergonié · Academic / Other
Sex
All
Age
18 Years – 120 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcomputed tomography
PROCEDUREpositron emission tomography
PROCEDUREradiofrequency ablation

Timeline

Start date
2005-05-02
Primary completion
2009-12-01
Completion
2011-05-01
First posted
2006-09-28
Last updated
2022-03-09
Results posted
2022-03-09

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00382252. Inclusion in this directory is not an endorsement.