Nanosecond Pulsed Field Ablation for Thyroid Cancer

Overseen By Victoria E Banuchi, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: High-grade malignancy, Metastases, Neck irradiation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called nanosecond pulsed field ablation (nsPFA) for papillary thyroid microcarcinoma. The goal is to evaluate how effectively this outpatient procedure targets and treats small thyroid tumors without requiring more invasive surgery. Individuals diagnosed with this type of thyroid cancer, with a tumor 1.5 cm or smaller and no signs of cancer spreading, might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this technique is safe for treating thyroid cancer?

Research has shown that nanosecond pulsed field ablation (nsPFA) is generally well-tolerated by patients. Studies on non-cancerous thyroid nodules indicate its safety. In one study, patients did not experience any internal scarring after treatment. Another study confirmed the procedure's initial safety, suggesting it could be a patient-friendly option.

Although these findings mainly apply to non-cancerous nodules, they offer insights into the safety of nsPFA for thyroid conditions. The procedure does not use heat, which may lower the risk of certain complications. As with any treatment, some side effects might occur, but current evidence suggests that nsPFA is a safe option worth considering. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for thyroid cancer, which often include surgery, radioactive iodine, or hormone therapy, Nanosecond Pulsed Field Ablation (nsPFA) is unique because it uses ultra-short electrical pulses to target and destroy cancerous cells. This innovative approach minimizes damage to surrounding healthy tissue and is performed as an outpatient procedure under local anesthesia or sedation, potentially reducing recovery times and hospital stays. Researchers are excited about nsPFA because it offers a less invasive alternative with the potential for fewer side effects, making it a promising option for improving patient quality of life.

What evidence suggests that this technique is effective for thyroid cancer?

Studies have shown that nanosecond pulsed field ablation (nsPFA), the treatment participants in this trial will receive, can effectively reduce thyroid nodule size. Specifically, nsPFA decreased thyroid nodule size by 71%, acting faster than traditional methods like radiofrequency ablation. This treatment uses short electrical pulses to target and destroy cancer cells without generating heat, protecting the surrounding healthy tissue. Early research suggests nsPFA holds promise for treating thyroid issues, including small papillary thyroid cancers. This method may offer a less invasive option with fewer complications compared to surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Victoria E Banuchi, MPH

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with a specific type of thyroid cancer (T1N0M0 Papillary Thyroid Carcinoma) that's very small in size (<= 1.5 cm), without spread to other areas. Participants must have normal blood counts, coagulation profiles, and thyroid function. They should not be pregnant, agree to use birth control if applicable, and commit to all study procedures.

Inclusion Criteria

For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure

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

Exclusion Criteria

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

My biopsy suggests a high-grade cancer.

My cancer has spread to nearby or distant lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including thyroid nodule volume changes and adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Nanosecond Pulsed Field Ablation

Trial Overview The trial is testing the CellFX nsPFA Percutaneous Electrode System on papillary thyroid microcarcinoma. It aims to evaluate how effective this non-surgical treatment is at managing these tiny tumors located in the thyroid gland.

How Is the Trial Designed?

Group I: Treatment with nsPFA Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40836795/

First-in-Human Clinical Feasibility Study of Ablation ... The objective of this study is to determine if a novel, cell-specific, nonthermal modality called nanosecond pulsed field ablation (nsPFA) can ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07226804

Nanosecond Pulsed Field Ablation in the Management of ... Study Details. NCT07226804. Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules. ClinicalTrials.gov.

3. investors.pulsebiosciences.com investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-announces-publication-first-human-data

Press Release - Pulse Biosciences Inc. Another key advantage of nsPFA over RFA is its significantly faster rate of thyroid nodule volume reduction: nsPFA achieved a 71% reduction ...

4. medicaleconomics.com medicaleconomics.com/view/pulse-biosciences-launches-clinical-study-for-thyroid-nodule-treatment

Pulse Biosciences launches clinical study for thyroid ... Pulse Biosciences' PRECISE-BTN trial uses nsPFA technology for benign thyroid nodule treatment, involving up to 50 patients across four sites.

5. facebook.com facebook.com/SarasotaMemorialHealthCareSystem/posts/-sarasota-memorials-kolschowsky-research-and-education-institute-is-offering-a-n/1242554994568324/

Sarasota Memorial Health Care System In a 10-center study, microwave ablation offered progression free survival rates and fewer complications than surgery in the treatment of a form ...

6. smh.com smh.com/Home/Services/Kolschowsky-Research-and-Education-Institute/Clinical-Trial/clinical-study-of-nanosecond-pulsed-field-ablation-for-people-with-benign-thyroid-nodules

Clinical Study of Nanosecond Pulsed Field Ablation for ... “The objective of this multicenter clinical study is to continue to build clinical evidence in support of this patient-friendly procedure by ...

7. biospace.com biospace.com/press-releases/pulse-biosciences-announces-publication-of-first-in-human-data-for-treatment-of-benign-thyroid-nodules-in-the-journal-thyroid

Pulse Biosciences Announces Publication of First-In- ... Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in ...

8. liebertpub.com liebertpub.com/doi/abs/10.1177/10507256251372166

First-in-Human Clinical Feasibility Study of Ablation ... Conclusions: This first-in-human study supports the initial safety/efficacy profile of the nsPFA electrode system in treating benign thyroid nodules. The ...