Actively Recruiting
Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-06-02
15
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of nanosecond pulsed field ablation (nsPFA) in treating patients with T1N0M0 papillary thyroid carcinoma (PTC), a type of thyroid cancer. The study aims to measure changes in thyroid nodule volume, including volume reduction rate, technique efficacy, and nodule regrowth after treatment. It also assesses the safety, complications, ultrasound changes over time, and effects on health-related quality of life following the procedure. Participants will receive thyroid ablation using the CellFX nsPFA Percutaneous Electrode System. This outpatient procedure is performed under local anesthesia or intravenous sedation. The treatment is guided by ultrasound to target thyroid nodules up to 1.5 cm in size without evidence of metastases or extrathyroidal extension. Throughout the study, participants will be monitored for safety and adverse events for about one year after treatment. Follow-up includes ultrasound evaluations to track nodule changes and assessments of quality of life. Participants must attend all scheduled visits and comply with study procedures to support the evaluation of treatment outcomes and safety.
CONDITIONS
Brief Title
Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 blood count, blood coagulation profile, and thyroid function test.
- For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Men must agree to use adequate contraception for 4 months after completion of study procedure.
You will not qualify if you...
- FNA findings suggestive of high-grade malignancy.
- Presence of regional or distant lymph node metastases.
- Participant had a history of previous neck irradiation.
- Females who are pregnant at time of enrollment.
- Participant has any condition or situation that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject's participation in the study.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia or intravenous sedation.
1 procedure visit (outpatient)
Duration - Up to 1 year
Participants are followed for up to 1 year after the procedure to evaluate safety, adverse events, and changes in thyroid nodule volume and quality of life.
Regular follow-up visits during the year
Trial Site Locations
Total: 2 locations
1
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
2
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
V
Victoria E Banuchi, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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