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New treatment option for Thyroid Cancer Patients
Official title Irreversible Electroporation for Recurrent or Metastatic Cervical Lymph Node Metastases From Thyroid Cancer: A Prospective Multicenter Single-Arm Study
ClinicalTrials.gov ID: NCT07328243
What this study is testing
- What it's testing
- This is a single-arm, open-label, multicenter, exploratory clinical trial designed to systematically evaluate the efficacy, safety, and patient benefit of ultrasound-guided irreversible electroporation (IRE) ablation for recurrent or metastatic cervical lymph node disease in patients with thyroid cancer after prior curative thyroid surgery and neck dissection. A total of 85 participants will be enrolled.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1: Voluntarily signs a written informed consent form
- 2: Age ≥ 18 years at the time of enrollment, male or female.
- 3: ECOG performance status score of 0 or 1.
- 4: Expected survival time ≥ 12 months.
- 5: Cervical lymph node metastases confirmed by pathology (core needle biopsy, fine-needle aspiration biopsy, or thyroglobulin testing in fine-needle...
You likely can't join if
- 1: History of severe bleeding tendency or coagulation disorders; presence of clinically significant bleeding within 1 month prior to the first...
- 2: History of myocarditis, cardiomyopathy, or malignant arrhythmias. Unstable angina, myocardial infarction, congestive heart failure, or vascular...
- 3: Patients who are unable to cooperate with treatment or unable to tolerate general anesthesia.
- 4: Presence of distant metastases outside the cervical region.
- 5: Presence of metastatic lymph nodes located in the level VII compartment of the neck.
- 6: Receipt of \^131I therapy within the past 6 months.
See the full eligibility criteria
Who can join
- 1: Voluntarily signs a written informed consent form
- 2: Age ≥ 18 years at the time of enrollment, male or female.
- 3: ECOG performance status score of 0 or 1.
- 4: Expected survival time ≥ 12 months.
- 5: Cervical lymph node metastases confirmed by pathology (core needle biopsy, fine-needle aspiration biopsy, or thyroglobulin testing in fine-needle aspiration washout fluid), and all of the following: ① Thyroid cancer...
- 6: Not suitable for repeat surgical resection or the patient refuses repeat surgery, or \^131I therapy is ineffective or the patient refuses \^131I therapy.
- 7: Adequate organ function as defined below: a) Hematologic (no transfusion of blood components or use of hematopoietic growth factors within 7 days prior to initiation of study treatment): i. Absolute neutrophil count...
- 8: Women of childbearing potential must undergo a urine or serum pregnancy test within 3 days prior to the first dose of study treatment (if the urine pregnancy test result cannot be definitively interpreted as...
- 9: Male people who have not been surgically sterilized and have female partners of childbearing potential must use effective contraception from screening until 180 days after the last dose of the study drug.
- 10: The subject is willing and able to comply with the visit schedule, treatment regimen, laboratory examinations, and other requirements of the study.
What rules you out
- 1: History of severe bleeding tendency or coagulation disorders; presence of clinically significant bleeding within 1 month prior to the first ablation treatment, including but not limited to gastrointestinal bleeding...
- 2: History of myocarditis, cardiomyopathy, or malignant arrhythmias. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease (such as an aortic aneurysm at risk of rupture) requiring...
- 3: Patients who are unable to cooperate with treatment or unable to tolerate general anesthesia.
- 4: Presence of distant metastases outside the cervical region.
- 5: Presence of metastatic lymph nodes located in the level VII compartment of the neck.
- 6: Receipt of \^131I therapy within the past 6 months.
- 7: Allergy to ultrasound or CT contrast agents, or inability to undergo contrast-enhanced imaging examinations for other reasons.
- 8: Patients who have undergone neck surgery, local ablation, chemotherapy, or immunotherapy/targeted therapy within the past 3 months.
- 9: In the opinion of the investigator, ablation needles cannot be safely placed.
- 10: Presence of metallic implants (plates, screws, etc.) or non-removable implanted catheters in the neck that may affect electric field distribution.
- 11: Concomitant untreated malignant tumors, or a history of any malignancy within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- 12: Concurrent enrollment in another clinical study.
- 13: Known history of psychiatric disorders, substance abuse, alcoholism, or illicit drug use.
- 14: Major surgery or severe trauma within 30 days prior to the first ablation treatment, or planned major surgery within 30 days after the first ablation treatment (as determined by the investigator).
- 15: History within 6 months prior to the first ablation treatment of esophageal or gastric fundal varices, severe peptic ulcer, unhealed wounds, gastrointestinal perforation, enterocutaneous fistula, intestinal...
- 16: Any arterial thromboembolic event, venous thromboembolism of grade ≥ 3 according to CTCAE version 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within...
- 17: Any past or current disease, treatment, or laboratory abnormality that may confound the study results, interfere with the subject's full participation in the study, or make participation not in the subject's best...
- 18: Local or systemic diseases not caused by malignant tumors, or tumor-related secondary diseases or symptoms that may lead to high medical risk and/or uncertainty in survival assessment, such as tumor-related...
- 19: Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.