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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000045
Enrollment
33
Registered
2005-08-06
Start date
2004-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable malignant lung tumor.

Interventions

A radiofrequency needle is inserted into the lung tumor percutaneously, and then, radiofrequency tumor ablation is performed.

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed malignant lung tumor. 2) Maximum diameter of the lesion on CT image between 1.0cm and 2.5cm. 3) No previous loco-regional therapy for the tumor. 4) Definitive accumulation of the tumor on FDG-PET study. 5) No vessel more than 5mm in diameter on the puncture route. 6) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions. 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 8) Expected survival more than 2 months. 9) Written informed consent.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Adverse events

Secondary

MeasureTime frame
Decrease of tumor accumulation on the image obtained by FDG-PET.

Countries

Japan

Contacts

Public ContactYasuaki Arai

JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital

jivrosgoffice@ml.res.ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026