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Evaluation of safety and efficacy of MWA for unresectable lung cancer

A prospective, single-center, single-arm, open label, feasibility study to evaluate safety and efficacy of MWA for unresectable lung cancer (SCIRO-2002) - SCIRO-2002

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062200029
Enrollment
10
Registered
2020-12-01
Start date
2021-11-10
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

primary lung cancer, metastatic lung cancer primary lung cancer, metastatic lung cancer

Interventions

MWA for primary or metastatic lung tumor

Sponsors

Tomita Koji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age of the patient 20 years old or older 2) Lung tumor is clinically diagnosed as NSCLC (include local tumor progression) or metastatic cancer 3) Refractory or unsuitable for surgical resection 4) Size of the target lesion smaller than 3.0 cm 5) Number of target lesion smaller than 3 in one lung and 6 in bilateral lung 6) On spirometry test, FEV1 is greater than 1.0 L and %VC is greater than 80% 7) No uncontrollable metastasis except on the lung 8) All of the following conditions are met a) White blood-cell count >= 3000 /mm3 b) platelet count >= 50,000 /mm3 c) Hemogrobin >= 7.5 g/dl d) Prothrombin time-international normalized ratio <= 1.5

Exclusion criteria

Exclusion criteria: 1)Absence of the safe needle insertion pathway 2)Presence of critical organ or vessel structures contact with target lesion 3)Active infectious desease except viral hapatitis 4)Active multiple cancers exept carcinoma in situ, intramucosal cancer, curative treated cancer, controlled breast cancer or prostate cancer 5)Interstitial pneumonia is observed on chest X-ray or CT imaging 6)Patients with cardiovascular implantable electronic devices 7)Patients receiving antiplatelet, thrombolytic, or anticoagulant drugs who are unable to stop the drug temporarily or replace it with heparin 8)Pregnant status 9)Inappropriateness of the candidate for the study judged by the investigators because of other reasons

Design outcomes

Primary

MeasureTime frame
Incidence rate of all severe complication until 1 month after the procedure

Secondary

MeasureTime frame
1)Incidence rate of all severe complication until 6 month after the procedure 2)Incidence rate of disorder during the procedure 3)Chest CT findings of ablated lesion 1 and 6month after the procedure 4)Technical success rate of target lesion within 7 days after the procedure 5)Technical efficacy of MWA 1 and 6 month after the procedure 6)Respiratory function assessments (%VC,FVC1) before and 1 and 6 months after the procedure

Contacts

Public ContactKoji Tomita

Okayama University Hospital

radiol@cc.okayama-u.ac.jp+81-86-235-7313

Outcome results

None listed

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