Nanosecond pulsed field ablation for small papillary thyroid cancer

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

This will test whether ultrasound-guided nanosecond pulsed field ablation can shrink or remove small (≤1.5 cm) papillary thyroid cancers in patients without spread.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: Radiation
• Locations: 2 sites (Sarasota, Florida and 1 other locations)
• Trial ID: NCT07218315 on ClinicalTrials.gov

What this trial studies

Researchers will use the CellFX nsPFA Percutaneous Electrode System to deliver ultrasound-guided nanosecond pulsed field ablation to T1N0M0 papillary thyroid carcinomas measuring ≤1.5 cm. The primary outcomes are changes in nodule volume, including volume reduction rate, technique efficacy, and nodule regrowth assessed by serial ultrasound. Secondary outcomes include procedure safety and complications, evolving ultrasound features of the treated nodules, and patient-reported health-related quality of life over time. Eligible participants must have Bethesda V or VI cytology, normal labs, no extrathyroidal extension or regional/distant metastases, and agree to scheduled follow-up at the treating center.

Who should consider this trial

Good fit: Ideal candidates are adults with T1N0M0 papillary thyroid carcinoma ≤1.5 cm confirmed by Bethesda V/VI cytology, no extrathyroidal extension or metastases, normal blood and thyroid tests, and the ability to undergo percutaneous ultrasound-guided treatment and follow-up.

Not a fit: Patients with tumors larger than 1.5 cm, evidence of extrathyroidal extension or regional/distant metastases, non-papillary histology, abnormal coagulation or thyroid function, or inability to attend follow-up visits are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could provide a minimally invasive option to shrink or eliminate small papillary thyroid cancers while avoiding or delaying surgery.

How similar studies have performed: Thermal ablation techniques such as radiofrequency and microwave have shown success for small papillary thyroid cancers, but nanosecond pulsed field ablation for thyroid cancer is a novel approach with limited clinical data to date.

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.

Where this trial is running

Sarasota, Florida and 1 other locations

• Sarasota Memorial Hospital — Sarasota, Florida, United States (Recruiting)
• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Victoria E Banuchi, MPH — M.D. Anderson Cancer Center
• Study coordinator: Victoria E Banuchi, MPH

Conditions Thyroid Carcinoma