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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00382252
First received: September 26, 2006
Last updated: May 12, 2011
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
 Procedure: computed tomography
Procedure: positron emission tomography
Procedure: radiofrequency ablation

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity, specificity, false-positive rate, and false-negative rate of PET/CT scan [ Designated as safety issue: No ]
  • Morbidity associated with RFA [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2005
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382252

Locations
France
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
Institut Bergonie
Bordeaux, France, 33076
Hopital Haut Leveque
Pessac, France, 33604
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: Francoise Bonichon, MD Institut Bergonié
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00382252     History of Changes
Other Study ID Numbers: CDR0000510046, IB-2005-30, INCA-RECF0142, IB-TEP-ARF-MPs-05
Study First Received: September 26, 2006
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
lung metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Lung Neoplasms
Neoplastic Processes
Pathologic Processes
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013