Evaluation of safety and efficacy of MWA for unresectable lung cancer

Phase 1

Recruiting

• Conditions: primary lung cancer, metastatic lung cancer

• Registration Number: JPRN-jRCTs062200029
• Lead Sponsor: Tomita Koji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified