Phase 0 Trial of Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer
University of Texas Southwestern Medical Center
Summary
The purpose of this study is to study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA Non-Small Cell Lung Cancer (NSCLC). TTField is a non-invasive treatment that uses low-intensity electrical fields to treat cancer. Resection is the medical term for surgically removing part or all of a tissue, structure, or organ.
Description
To study the clinical and biologic effects of Tumor Treatment Fields (TTFields) in patients undergoing resection of stage I-IIIA NSCLC. Participants in this study will have a blood sample collected as well as vital signs along with a tumor tissue sample and tumor scan. Once it has been determined the participant can enroll into this study, he/she will come to the clinic for 5 scheduled visits over a period of 2 months .
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of stage I-IIIA NSCLC planned for surgical resection. 2. Eastern Cooperative Oncology Group (ECOG) 0-2 performance status. 3. Willingness and ability to undergo planned correlative studies, including imaging tests. 4. Fresh biopsy diagnostic material obtained from standard of care procedure to perform baseline correlatives (10-15 slides)-if not available, enrollment will be considered on a case-by-case basis after discussion with and approval by the Lead Site PI or Lead Site Co-Principal Investigator. 5. Ability to understand and the willingness to sign a writ…
Interventions
- DeviceNovoTTF-200T System
Exposure/Frequency: 150 kHz Route: Transdermal through patented microarray system to the hemithorax affected with cancer, 2-4 week duration, target 18 hours/day (on average)
Location
- The University of Texas Southwestern Medical CenterDallas, Texas