Nanosecond Pulsed Field Ablation for Early Papillary Thyroid Cancer
This clinical trial is about testing the safety and adverse events of Nanosecond Pulsed Field Ablation as a treatment for early Papillary Thyroid Cancer, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (v5.0).
CellFX nsPFA Percutaneous Electrode System
Endocrine System Diseases+4
+ Endocrine Gland Neoplasms
+ Head and Neck Neoplasms
Treatment Study
Summary
Study start date: April 30, 2026
Actual date on which the first participant was enrolled.The study aims to explore a new treatment method for individuals with a specific type of thyroid cancer, known as T1N0M0 papillary thyroid carcinoma. This condition is characterized by a small cancerous nodule in the thyroid gland. The study focuses on using a technique called nanosecond Pulsed Field Ablation (nsPFA™), guided by ultrasound, to treat these nodules. This approach seeks to reduce the size of the cancerous nodules and prevent them from growing back, potentially offering a less invasive alternative to traditional treatments like surgery. This research is important as it could lead to more precise and effective treatment options for patients, minimizing the impact on their quality of life. Participants in the study undergo a procedure where the nsPFA™ technique is applied to the thyroid nodule using a specialized device called the CellFX Percutaneous Electrode (PE) System. The treatment is delivered directly to the affected area under ultrasound guidance. Researchers will measure the success of this treatment by examining changes in the size of the thyroid nodules and monitoring for any regrowth over time. They also assess the safety of the procedure and any potential side effects. Additionally, the study tracks the overall quality of life of the participants to see how it changes following treatment, ensuring that the benefits outweigh any risks associated with the procedure.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 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 (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: ). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study procedure. Exclusion Criteria: * 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, in the opinion of the site Investigator, that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject's participation in the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The University of Texas M. D. Anderson Cancer Center
Houston, United StatesOpen The University of Texas M. D. Anderson Cancer Center in Google Maps