A phase I/II study of percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0203)

UMIN ID: C000000045

Registered date:06/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable malignant lung tumor.
• Date of first enrollment: 2004/04/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A radiofrequency needle is inserted into the lung tumor percutaneously, and then, radiofrequency tumor ablation is performed.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Decrease of tumor accumulation on the image obtained by FDG-PET.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Unmeasurable lesion on CT. 2) Lesion with ground-glass opacity on CT. 3) Lesion adjacent to heart, mediastinum, pleura and vessel or bronchus more than 5mm in diameter. 4) Active inflammation or infection. 5) Fever above 38 degrees Celsius. 6) Cardiac pacemaker. 7) Anti-coagulant medication. 8) Severe dysfunction in the contra-lateral lung. 9) Pulmonary hypertension. 10) Difficulty of normal activity due to cerebrovascular disease, prior neurosurgery or trauma. 11) Pregnancy.

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare