癌研連線CancerLink
招募中 NCT07487064

Galvanize Aliya® EX脈衝電場（PEF）治療及切除研究

肺癌不適用

一項前瞻性、單臂、非隨機、單中心、開放標籤的治療及切除研究，隨訪患者至手術切除。本研究旨在評估Aliya EX系統利用脈衝電場（PEF）能量傳遞消融肺部病灶的安全性與可行性。

適應症：Lung Cancer

收案條件

納入條件

  • Presence of at least one lesion in the lung measuring ≥ 1.5 cm and ≤ 4 cm diameter by computed tomography (CT) size estimate deemed suitable for PEF ablation per institutional guidelines.
  • High probability of malignancy as determined by the investigator.
  • Patient has been deemed a candidate for definitive lung tissue resection per institutional SOC.
  • Patient is, in the opinion of the Principal Investigator (PI), able to adhere to and undergo the PEF and surgical procedures.
  • Patient is able to tolerate general anesthesia.
  • Patient is 18 years of age or older.
  • Patient has provided informed consent.

排除條件

  • Patient requires neoadjuvant therapy for the disease for which surgical resection is intended.
  • Patient is receiving concurrent cancer treatment (e.g., external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy).
  • Patient has received effective treatment for the target lesion in the last two years prior to the date of consent.
  • Patient has undergone prior pneumonectomy.
  • Patient has a serious medical condition that, in the Principal Investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to PEF ablation (e.g., major organ dysfunction, active autoimmune disease, immune compromised or receiving immune modulating medication that has resulted in substantial clinical change).
  • Patient is receiving oral corticosteroid therapy (\>10mg/day or equivalent) within 30 days of the PEF procedure.
  • Patient is currently enrolled in another interventional clinical trial.
  • Patient has a physical or psychological condition that would impair study participation or jeopardize the safety or welfare of the patient.
  • Women of childbearing potential who are pregnant, nursing, or planning to get pregnant during their participation in the study.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。