NCT06791005 A Clinical Study on the Benefits of Carbon Nanoparticles Injection Time in Patients With Thyroid Cancer.
| NCT ID | NCT06791005 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital of Xi'an Jiaotong University |
| Condition | Papillary Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-01-01 with a primary completion date of 2025-06-30.
⚠ 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
The detection rate of thyroid cancer (PTC) has increased rapidly in recent years. Except undifferentiated cancer, surgery is still one of the most important treatments for all types of thyroid cancer, and there is a consensus to use the lobes of the gland as the minimum extent of resection. In the meantime, a basic consensus has been reached that central zone lymph node (VI) dissection is the minimum extent of lymph node dissection. In clinical practice, neck surgery and lumpectomy are mostly performed. Hypoparathyroidism and recurrent laryngeal nerve injury are the most common complications of radical surgery for thyroid cancer, both in open surgery and the luminal approach. Once these complications occur, they have a serious impact on the quality of life of patients in the postoperative period. A number of contrast agents are now being used to help minimize complications. Carbon nanoparticles are an effective and non-harmful negative developer, and many studies have confirmed that carbon nanoparticles can be used to identify parathyroid glands in thyroid surgery. Intraoperative injection of nanocarbon is effective in increasing the quality of intraoperative parathyroid detection and lymph node clearance and reducing adverse effects, such as postoperative hypokalemia.However, there is no complete clinical guideline for preoperative intraglandular injection of carbon nanoparticles, and there is no standardized dosage for appropriate injection time, injection dose, and injection method. At the same time, there is still the problem of carbon nanoparticle leakage. At our medical center, we have found that preoperative injection of carbon nanoparticles via ultrasound-guided fine needle puncture may yield better results by reducing CNS exudation in the surgical area. In this study, we will collect more than 400 patients who underwent thyroidectomy in 2025 and underwent carbon nanoparticle injections at different time points and analyzed their intraoperative and postoperative conditions as a basis for analyzing the difference in patient benefits between preoperative and intraoperative carbon nanoparticle injections and to provide data to support the clinical use of carbon nanoparticles.
Eligibility Criteria
Inclusion Criteria: * Preoperative pathological assessment indicated the presence of thyroid cancer with a maximum diameter of less than 4 cm. * Postoperative pathological evaluation confirmed bilateral thyroid cancer or lateral lymph node metastasis. * Vocal cord examination conducted one week prior to surgery revealed no abnormalities. * The patient had no history of prior thyroid surgery and required a total thyroidectomy. * Blood pressure was stably controlled. * The patient regained consciousness and was able to communicate normally. Exclusion Criteria: * Prior to enrollment, the patient had received radiotherapy, chemotherapy, or isotope therapy. * A documented history of thyroid surgery. * Age under 16 years. * Known allergies to the medications under investigation or an inability to tolerate surgical intervention. * Presence of a retrosternal thyroid tumor. * Tumor invasion of the parathyroid glands and/or the recurrent laryngeal nerve during surgical procedures. * Postoperative pathology suggestive of medullary carcinoma or undifferentiated carcinoma. * Development of a postoperative tracheal fistula.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06791005 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Papillary Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06791005 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06791005 currently recruiting?
Yes, NCT06791005 is actively recruiting participants. Contact the research team at individualliu@163.com for enrollment information.
Where is the NCT06791005 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06791005 clinical trial?
NCT06791005 is sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. The trial plans to enroll 400 participants.
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