Evaluation of safety and efficacy of MWA for unresectable lung cancer

JRCT ID: jRCTs062200029

Registered date:01/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: primary lung cancer, metastatic lung cancer
• Date of first enrollment: 10/11/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): MWA for primary or metastatic lung tumor

Outcome(s)

• Primary Outcome: Incidence rate of all severe complication until 1 month after the procedure

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tomita Koji