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Recruiting NCT07218315

NCT07218315 Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma

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Clinical Trial Summary
NCT ID NCT07218315
Status Recruiting
Phase
Sponsor M.D. Anderson Cancer Center
Condition Thyroid Carcinoma
Study Type INTERVENTIONAL
Enrollment 15 participants
Start Date 2026-02-11
Primary Completion 2029-01-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
CellFX nsPFA Percutaneous Electrode System

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 15 participants in total. It began in 2026-02-11 with a primary completion date of 2029-01-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T

Eligibility 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.

Contact & Investigator

Central Contact

Victoria E Banuchi, MPH

✉ vebanuchi@mdanderson.org

📞 713-563-7600

Principal Investigator

Victoria E Banuchi, MPH

PRINCIPAL INVESTIGATOR

M.D. Anderson Cancer Center

Frequently Asked Questions

Who can join the NCT07218315 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07218315 currently recruiting?

Yes, NCT07218315 is actively recruiting participants. Contact the research team at vebanuchi@mdanderson.org for enrollment information.

Where is the NCT07218315 trial being conducted?

This trial is being conducted at Sarasota, United States, Houston, United States.

Who is sponsoring the NCT07218315 clinical trial?

NCT07218315 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Victoria E Banuchi, MPH at M.D. Anderson Cancer Center. The trial plans to enroll 15 participants.

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