Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Outcomes of Radiofrequency Ablation of Lung Tumors

This study has suspended participant recruitment.
RITA Medical Systems
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: January 18, 2006
Last updated: February 12, 2014
Last verified: February 2014

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) of pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Condition Intervention
Pulmonary Metastases
Procedure: Radiofrequency ablation of pulmonary malignancies
Behavioral: Quality of life assessment
Behavioral: Assessment of pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Outcomes of Radiofrequency Ablation of Lung Tumors

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Assess overall survival, progression-free survival and clinical response after RFA [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize QOL before and after RFA treatment [ Time Frame: Every 3 months for 1 year then annually ] [ Designated as safety issue: No ]
  • To assess procedure related outcomes after RFA of lung tumors, in particular, measuring length of stay, morbidity and mortality and requirements for chest tube drainage [ Time Frame: Within 30 days of RFA procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: September 2003
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Radiofrequency ablation of pulmonary malignancies
    Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
    Behavioral: Quality of life assessment
    Quality of life assessment is administered prior to the Radiofrequency ablation procedure and every 3 months for 1 year following the procedure.
    Behavioral: Assessment of pain
    Pain scores are obtained prior to the procedure, daily X 7 starting on the day of surgery, and then every 3 months for 1 year.
  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seeking minimally invasive treatment for pulmonary malignancies.


Inclusion Criteria:

  • Have stage I or II primary lung cancer and who are felt not to be candidates for resection based upon co-morbid disease or who refuse lung resection.
  • Have metastatic tumors to the lung, and who meet criteria for metastasectomy but who are felt not to be candidates for resection of all metastases. All metastases should be treatable by RFA alone or in combination with resection.
  • Have positive tissue diagnosis by previous resection (less than 6 months) or by radiologic biopsy.
  • Have clinically suspicious disease defined as a new lesion on chest CT or a suspicious PET scan.
  • Have RF ablation target lesions of 4 centimeters or less in diameter.

Exclusion Criteria:

  • If the lesion is centrally located, less than 3 centimeters from the hilum.
  • If the target lesion is greater than 4 centimeters in diameter.
  • If the lesion is metastatic and the primary site is not controlled.
  • If extra-thoracic metastatic disease is present.
  • If there are more than 3 tumors in one lung.
  • If there are greater than 6 metastatic tumors in total (bilateral).
  • If it is felt that all metastases cannot be treated by RFA alone or in combination with resection.
  • If the patient is pregnant or nursing at the time of the procedure.
  • If the patient has malignant pleural effusion.
  • If the patient is unwilling or unable to provide consent for the procedure.
  • If the patient is less than 18 years of age (the short form [SF]-36 is not designed for patients less than 18 years of age).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00280189

United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
RITA Medical Systems
Principal Investigator: James Luketich, MD UPMC - Heart, Lung, and Esophageal Surgery Institute
  More Information

No publications provided

Responsible Party: University of Pittsburgh Identifier: NCT00280189     History of Changes
Other Study ID Numbers: 0302108, #02-033
Study First Received: January 18, 2006
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Radiofrequency ablation
Pulmonary malignancies
Primary lung cancer
Pulmonary metastasis
Primary lung tumors
Secondary lung tumors
Coagulation necrosis of soft tissue tumors

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Lung Diseases
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on February 26, 2015