Thyroid CarcinomaNCT07218315
Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
A study testing CellFX nsPFA Percutaneous Electrode System in people with Thyroid Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma
- What is being tested?
- CellFX nsPFA Percutaneous Electrode System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2026to 31 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Victoria E Banuchi, MPH, 713-563-7600 ext. 3, vebanuchi@mdanderson.org
Victoria E Banuchi, MPH
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Ralph Tufano, MD, 713-563-7600, ralph-tufano@smh.com
Ralph Tufano, MD
About this study
This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T
Read the detailed description
Primary Objective:
To evaluate the efficacy of ultrasound-guided nsPFA™ in the treatment of patients with T1N0M0 PTC as measured by the thyroid nodule volume changes including volume reduction rate (VRR), technique efficacy (TE) and nodule regrowth (NR) during post procedure follow-up.
Secondary Objectives:
To assess the clinical safety and complications of the CellFX Percutaneous Electrode (PE) System
To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA.
To determine the health-related quality of life changes over time induced by ultrasound-guided nsPFA.
- Conditions
- Thyroid Carcinoma
- Being tested
- CellFX nsPFA Percutaneous Electrode System
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX nsPFA Percutaneous Electrode SystemDevice
Patients will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with nsPFA | Experimental | Participants will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation. Receives: Device: CellFX nsPFA Percutaneous Electrode System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start11 Feb 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria E Banuchi, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218315
- Sponsor's protocol ID
- 2025-0726
- Other IDs
- NCI-2025-07697
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT07218315
- Acronym / sponsor ID
- 2025-0726
- Conditions
- Thyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T
Detailed description
Primary Objective:
To evaluate the efficacy of ultrasound-guided nsPFA™ in the treatment of patients with T1N0M0 PTC as measured by the thyroid nodule volume changes including volume reduction rate (VRR), technique efficacy (TE) and nodule regrowth (NR) during post procedure follow-up.
Secondary Objectives:
To assess the clinical safety and complications of the CellFX Percutaneous Electrode (PE) System
To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA.
To determine the health-related quality of life changes over time induced by ultrasound-guided nsPFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with nsPFA | Experimental | Device: CellFX nsPFA Percutaneous Electrode SystemParticipants will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellFX nsPFA Percutaneous Electrode SystemPatients will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation. | Device | Treatment with nsPFA |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria E Banuchi, MPH principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX nsPFA Percutaneous Electrode System in people with Thyroid Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria E Banuchi, MPH (713-563-7600 ext. 3, vebanuchi@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.