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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Prince of Wales Hospital
  Shatin, Hong Kong Recruiting

Study contacts

• Study coordinator: Maria Plentl, MSN
• Email: mplentl@galvanizetx.com
• Phone: (650) 268-4252

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden

  This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.

  Recruiting Tongji Hospital · Hubei, Wuhan · NCT07912190

• Urine VOC Test to Detect Lung Cancer in Never Smokers

  A urine test that looks for volatile compounds is tested to see if it can help detect lung cancer in adults who have never smoked.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07871656

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment

  This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07816263

• ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients

  This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.

  Recruiting at 2 sites Tam Anh Research Institute · Hanoi, Hanoi and 1 other locations · NCT07808164

• Olive oil before lung cancer surgery to see if it lowers chylothorax

  This study tests whether drinking 40 mL of extra-virgin olive oil a few hours before lung cancer surgery can reduce chylothorax after tumor removal.

  Recruiting Fudan University · Shanghai, Xuhui · NCT07807696

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.