Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-005059
- Jacksonville, Florida: 23-005059
NCT ID: NCT05890872
Sponsor Protocol Number: CSP-00018
About this study
The purpose of this early feasibility study (EFS) is to evaluate the safety of delivering Aliya pulsed electric fields ablation in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV
non-small cell lung cancer (NSCLC) requiring biopsy.
- Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm
in longest diameter and deemed by the investigator to be suitable per study procedural
guidelines for treatment with PEF.
- Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
- In the opinion of the investigator, the patient is not a surgical candidate for
curative intent, or the patient has refused surgery.
- Life expectancy ≥ 6 months.
Exclusion Criteria:
- Patient has received any prior cancer therapy for current tumor(s) to be treated with
PEF.
- Patient is scheduled to receive investigational therapies (including device-based
therapy) that may interfere with the study endpoints while on this study.
- Patient has clinical evidence of leptomeningeal disease or brain metastases that
require SOC treatment within 4 weeks post-PEF treatment.
- Patient with active, known, or suspected autoimmune disease.
- Patient with type I diabetes mellitus, hypothyroidism only requiring hormone
replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring
systemic treatment, or conditions not expected to recur in the absence of an external
trigger are permitted to enroll.
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) is not considered a form
of systemic treatment and is allowed.
- Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone
or equivalent) or other immunosuppressive medications within 30 days prior to study
enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily
prednisone or equivalent are permitted in the absence of active autoimmune disease.
- Patient has any history of primary immunodeficiency.
- Patient has clinical signs or symptoms of active tuberculosis infection.
- Patient has documented evidence of acute hepatitis or has an active or uncontrolled
infection.
- Patient has undergone major surgery (excluding placement of vascular access) within 28
days prior to study enrollment or has planned major surgeries while enrolled in the
study,
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/13/24. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available