Clinical trial NCT00382252: PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases
Official title: Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
lung metastases
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2006-09-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of True Positive Plus True Negative Patients
timeFrame: 3 months after RFA
Secondary outcomes:
measure: Percentage of True Positive Patients
timeFrame: 3 months after RFA
measure: Percentage of True Negative Patients
timeFrame: 3 months after RFA
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Bordeaux
country: France
facility: Institut Bergonie
city: Pessac
country: France
facility: Hopital Haut Leveque
Study officials:
affiliation: Institut Bergonié
name: Francoise Bonichon, MD
role: STUDY_CHAIR
References:
citation: Bonichon F, Palussiere J, Godbert Y, Pulido M, Descat E, Devillers A, Meunier C, Leboulleux S, de Baere T, Galy-Lacour C, Lagoarde-Segot L, Cazeau AL. Diagnostic accuracy of 18F-FDG PET/CT for assessing response to radiofrequency ablation treatment in lung metastases: a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1817-27. doi: 10.1007/s00259-013-2521-9. Epub 2013 Sep 17.