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Nanosecond Pulsed Field Ablation for Early Papillary Thyroid Cancer

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Study Aim

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).

What is being tested

CellFX nsPFA Percutaneous Electrode System

Device
Who is being recruted

Endocrine System Diseases+4

+ Endocrine Gland Neoplasms

+ Head and Neck Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Study ContactVictoria E Banuchi, MPH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleNanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
NCT07218315
Principal SponsorM.D. Anderson Cancer Center
Study ContactVictoria E Banuchi, MPH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Endocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteThyroid DiseasesThyroid Neoplasms

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation.

Study 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

Suspended

The University of Texas M. D. Anderson Cancer Center

Houston, United StatesOpen The University of Texas M. D. Anderson Cancer Center in Google Maps
Recruiting soonOne Study Center