A Clinical Study of Aliya Pulsed Electric Fields | Clinical Research Studies Listing

A Clinical Study of Aliya Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment of Advanced Cancer

Recruiting

22-100 years

All

Phase 4

10 participants needed

1 Location

Brief description of study

The Investigation Device Exemption (IDE) study will evaluate the safety of delivering Aliya PEF 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.

Detailed description of study

A prospective, single-arm, non-randomized, multi-center, open-label feasibility IDE study. The total study duration from enrollment to follow-up of the last subject last visit is expected to be two years. The follow-up for each individual subject is defined to be 12 months after PEF treatment.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: metastatic cancer,non-small cell lung cancer NSCLC)
Age: Between 22 Years - 100 Years
Gender: All

Inclusion

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

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

Updated on 22 Aug 2024. Study ID: 855278

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