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

NCT ID: NCT00382252

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-02
• Study Completion Date: 2011-05-31

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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-FDG PET/CT + RFA

18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA.

RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes.

CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA.

Group Type: EXPERIMENTAL

computed tomography

Intervention Type: PROCEDURE

positron emission tomography

Intervention Type: PROCEDURE

radiofrequency ablation

Intervention Type: PROCEDURE

Interventions

computed tomography

Intervention Type: PROCEDURE

positron emission tomography

Intervention Type: PROCEDURE

radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francoise Bonichon, MD

Role: STUDY_CHAIR

Institut Bergonié

Locations

Centre Hospitalier de la Cote Basque

Bayonne, , France

Institut Bergonie

Bordeaux, , France

Hopital Haut Leveque

Pessac, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 24042540 (View on PubMed)

Other Identifiers

IB-2005-30

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0142

Identifier Type: -

Identifier Source: secondary_id

IB-TEP-ARF-MPs-05

Identifier Type: -

Identifier Source: secondary_id

CDR0000510046

Identifier Type: -

Identifier Source: org_study_id