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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:
ClinicalTrials.gov Identifier:
NCT00382252
First Posted: September 28, 2006
Last Update Posted: May 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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: None (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:


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)

Secondary Outcome Measures:
  • Sensitivity, specificity, false-positive rate, and false-negative rate of PET/CT scan
  • Morbidity associated with RFA
  • Overall survival

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00382252     History of Changes
Other Study ID Numbers: CDR0000510046
IB-2005-30
INCA-RECF0142
IB-TEP-ARF-MPs-05
First Submitted: September 26, 2006
First Posted: September 28, 2006
Last Update Posted: May 13, 2011
Last Verified: July 2009

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes