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

Institut Bergonié

Status: Completed

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

Treatments: Procedure: positron emission tomography; Procedure: radiofrequency ablation; Procedure: computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT00382252

IB-2005-30

CDR0000510046

IB-TEP-ARF-MPs-05

INCA-RECF0142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

18F-FDG PET/CT + RFA

Experimental group

Description:

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.

Treatment:

Procedure: positron emission tomography

Procedure: radiofrequency ablation

Procedure: computed tomography