Status:
COMPLETED
Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer
Lead Sponsor:
Galvanize Therapeutics, Inc.
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 feasibi...
Detailed Description
This study is to evaluate the safety and initial feasibility of Pulsed Electric Field (PEF) treatment of NSCLC tumors prior to surgical resection. Treatment may be delivered via either an endoluminal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04732520
Start Date
March 31 2021
End Date
February 13 2024
Last Update
July 19 2024
Active Locations (4)
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1
Prince of Wales Hospital
Shatin, Hong Kong
2
Radboud University Medical Center
Nijmegen, Netherlands, 6500HB
3
Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz
Madrid, Spain, 28040
4
Hospital Universitario de Salamanca
Salamanca, Spain, 37007