Non Small Cell Lung Cancer Clinical Trial
— INCITE ESOfficial title:
The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
Verified date | January 2023 |
Source | Galvanize Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, two-arm, non-randomized, concurrently controlled, multi-center, open-label, treat and resect study following patients to 1 year. The study is designed to evaluate the safety and feasibility of the Aliya System for the ablation of solid tumors using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed NSCLC 8th ed. Stage IA2, IA3 or IB (>1 to ≤4 cm solitary lesion) who are surgical candidates and have not received treatment for the index tumor in the last two years.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | January 2024 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Presence of solitary NSCLC nodule 8th ed. stage IA2, IA3 or IB - Nodule measuring > 1 cm and =4 cm diameter by CT size estimate (e.g. T1b, T1c, T2a), with a minimum 1 cm solid component - High pre-procedure probability of malignancy as determined by the investigator - Patient has been evaluated by a thoracic surgeon and deemed a candidate for definitive lung tissue resection - Patient is, in the opinion of the principal investigator, able to adhere to and undergo bronchoscopy, surgical procedure and post-treatment care Exclusion Criteria: - Additional pulmonary nodules requiring intervention - Patient is receiving concurrent cancer treatment (e.g. external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy) or has received treatment for the index tumor in the last two years - Patient has implanted lung devices or electronic devices - Patient has N1 disease - Patient is immune compromised or receiving immune modulating medication - Recurrent NSCLC within 2 years of initial definitive treatment - Previous checkpoint inhibitor treatment for another cancer |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Sha Tin | |
Netherlands | Radboud University Medical Center | Nijmegen | |
Spain | Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz | Madrid | |
Spain | Hospital Universitario de Salamanca | Salamanca |
Lead Sponsor | Collaborator |
---|---|
Galvanize Therapeutics, Inc. |
Hong Kong, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device and Procedure related serious adverse event rate | The rate of system-related and procedure-related serous adverse events (SAEs) | 30 days | |
Secondary | Technical Success rate | The frequency with which the clinician can access the index tumor and delivery energy | Acute procedure |
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