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Completed

NCT Number: NCT00382252

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

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.

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de la Cote Basque, Bayonne, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Positron Emission Tomography

Procedure

Radiofrequency ablation

Procedure

Primary outcomes

  1. Percentage of True Positive Plus True Negative Patients

    Time frame: 3 months after RFA

    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).

Secondary outcomes

  1. Percentage of True Positive Patients

    Time frame: 3 months after RFA

    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)

  2. Percentage of True Negative Patients

    Time frame: 3 months after RFA

    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)

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: TEPARF

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Sep 28, 2006
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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