Status:
SUSPENDED
Study of Outcomes of Radiofrequency Ablation of Lung Tumors
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
RITA Medical Systems
Conditions:
NSCLC
Pulmonary Metastases
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
The use of RF ablation in pulmonary tissue is not new. However previous reports have primarily been descriptions of technique and early procedural outcomes. Follow-up studies have been lacking. This s...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00280189
Start Date
September 1 2003
End Date
February 1 2026
Last Update
April 16 2025
Active Locations (1)
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1
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232