Study of Outcomes of Radiofrequency Ablation of Lung Tumors

NCT00280189 | Suspended

• 2 other identifiers: STUDY20050042#02-033
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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 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).

Conditions

NSCLC; Pulmonary Metastases

Keywords

Radiofrequency ablation; Pulmonary malignancies; Primary lung cancer; Pulmonary metastasis; Primary lung tumors; Secondary lung tumors; Coagulation necrosis of soft tissue tumors

Outcome Measures

Primary Outcomes (1)

• Assess overall survival, progression-free survival and clinical response after RFA

  Until disease progression or death

Secondary Outcomes (2)

• To characterize QOL before and after RFA treatment

  Every 3 months for 1 year then annually

• 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

  Within 30 days of RFA procedure

Interventions

Radiofrequency ablation of pulmonary malignancies PROCEDURE

Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.

Quality of life assessment BEHAVIORAL

Quality of life assessment is administered prior to the Radiofrequency ablation procedure and every 3 months for 1 year following the procedure.

Assessment of pain BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking minimally invasive treatment for pulmonary malignancies.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• RITA Medical Systems: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Study Officials

• James Luketich, MD

  UPMC - Department of Cardiothoracic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: September 1, 2003
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

US (1)