Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
M.D. Anderson Cancer Center
Summary
This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T
Description
Primary Objective: To evaluate the efficacy of ultrasound-guided nsPFA™ in the treatment of patients with T1N0M0 PTC as measured by the thyroid nodule volume changes including volume reduction rate (VRR), technique efficacy (TE) and nodule regrowth (NR) during post procedure follow-up. Secondary Objectives: To assess the clinical safety and complications of the CellFX Percutaneous Electrode (PE) System To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA. To determine the health-related quality of life changes over time induced by ultrasound-g…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must provide voluntary, written informed consent to participate in this clinical investigation. * Participant agrees to comply with all study procedures, including all follow-up visits. * Participant with a Bethesda VI cytology (tumor size \<= 1.5 cm, no known regional/distant metastases) * Participant with a Bethesda V cytology and normal calcitonin levels. * Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional metastases. * Participant must have normal complete bloo…
Interventions
- DeviceCellFX nsPFA Percutaneous Electrode System
Patients will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation.
Locations (2)
- Sarasota Memorial HospitalSarasota, Florida
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas