Pre-surgery Aliya EX pulsed electric field treatment for lung tumors

A Targeted Ablation and Resection Study With Galvanize Aliya® EX Pulsed Electric Field (PEF) Technology

This study will try the Aliya EX pulsed electric field device to ablate 1.5–4 cm lung tumors in adults who are scheduled for surgical removal.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Galvanize Therapeutics, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shatin)
• Trial ID: NCT07487064 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label treat-and-resect study at one clinical site that will enroll up to 25 adults with suspected or confirmed malignant pulmonary lesions sized 1.5–4 cm. Treated patients will receive Aliya EX pulsed electric field (PEF) ablation delivered either bronchoscopically or percutaneously at the investigator's discretion, followed by planned surgical resection. The study is designed to collect safety data and measure technical success of PEF delivery prior to standard surgical removal. Patients must be surgical candidates, able to tolerate general anesthesia, and must not have received recent treatment for the index lesion.

Who should consider this trial

Good fit: Adults with suspected or confirmed malignant lung lesions measuring 1.5–4 cm who are candidates for definitive surgical resection and can tolerate general anesthesia are the intended participants.

Not a fit: Patients who require neoadjuvant therapy, are receiving concurrent cancer treatments, or whose lesions fall outside the 1.5–4 cm size window are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, PEF ablation with the Aliya EX could offer a safe preoperative way to destroy or reduce tumor tissue and inform local-control strategies for lung cancer.

How similar studies have performed: Pulsed electric field and electroporation techniques have shown early promising results in other organs, but PEF for pulmonary lesions remains relatively new with limited clinical data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Shatin

• Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)

Study contacts

• Study coordinator: Maria Plentl, MSN

Conditions Lung Cancer