Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer
NYU Langone Health
Summary
This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed and histologically confirmed PDAC by biopsy * Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter * ECOG performance status 0-2 * Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis * Lesions between 1 - 4cm in size Exclusion Criteria: * Patients that show evidence of distant metastasis * Endoscopically non-accessible mass * Pregnant patients * Inability to provide informed cons…
Interventions
- DrugChemotherapy
Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.
- DeviceEndoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)
EUS-RFA will be delivered using the EUSRA RF Electrode, which is a sterile, single-use electrosurgical accessory for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator (VIVA Combo RF Generator). The device will be used during a routine EUS, which is a minimally invasive procedure used to assess gastrointestinal diseases. Each EUS-RFA procedure will last approximately 60 minutes.
Location
- Tisch HospitalNew York, New York