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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

— TEPARF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382252
• Other study ID #: CDR0000510046
• Secondary ID: IB-2005-30INCA-R
• Status: Completed
• Phase: N/A
• Start date: May 2, 2005
• Est. completion date: May 2011

Study information

• Verified date: March 2022
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer
• Radiologically suspected pulmonary metastases
• May be confirmed histologically or by specific markers
• Less than 6 lesions
• Lesions < 40 mm
• Prior positron emission tomography shows 1 hyperfixation (standard uptake variable > 3) at the level of lesions to be treated
• Lesions must not be attached to or next to major mediastinal structures
• Radiofrequency ablation planned as treatment

PATIENT CHARACTERISTICS:

• Life expectancy > 6 months
• No uncontrolled medical condition, including any of the following:
• Psychiatric condition
• Infection
• Coronary insufficiency
• New York Heart Association class III-IV heart disease
• No other serious condition
• No contraindication to general anesthesia
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

• At least 30 days since prior participation in an investigational study
• At least 30 days since prior chemotherapy
• No other concurrent investigational agents

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• computed tomography

• positron emission tomography

• radiofrequency ablation

Locations

Country	Name	City	State
France	Centre Hospitalier de la Cote Basque	Bayonne
France	Institut Bergonie	Bordeaux
France	Hopital Haut Leveque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of True Positive Plus True Negative Patients	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).	3 months after RFA
Secondary	Percentage of True Positive Patients	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)	3 months after RFA
Secondary	Percentage of True Negative Patients	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)	3 months after RFA