A Clinical Study on the Benefits of Carbon Nanoparticles Injection Time in Patients With Thyroid Cancer.

January 18, 2025 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

A Comparative Study of Preoperative and Intraoperative Carbon Nanoparticles Injection in Patients Undergoing Thyroid Cancer Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

1. Use of drugs: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Preoperative Injection Before Partial Thyroidectomy Group
Patients in this group will undergo partial thyroidectomy and preoperative injection of carbon nanoparticles.
Drug: Preoperative Injection of Carbon Nanoparticles
1.Medication: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. 2.Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.
Active Comparator: Intraoperative Injection During Partial Thyroidectomy Group
Patients in this group will undergo partial thyroidectomy and intraoperative injection of carbon nanoparticles.
Drug: Intraoperative Injection of Carbon Nanoparticles
Intraoperative injection of carbon nanoparticles: After exposing the thyroid peritoneum, 0.1 mL of carbon nanoparticles was injected into both sides of normal thyroid tissue using a syringe (1 mL). Two spots were needed for each flap, and the total volume of injected carbon nanoparticles was 0.4 mL. Finally, the needle was gently backed up under negative pressure to prevent the leakage of carbon nanoparticles.
Experimental: Preoperative Injection Before Total Thyroidectomy Group
Patients in this group will undergo total thyroidectomy and preoperative injection of carbon nanoparticles.
Drug: Preoperative Injection of Carbon Nanoparticles
1.Medication: Carbon nanoparticles, Chongqing Lemay Pharmaceutical Co. Ltd., production license, Food and Drug Administration Production License No. (China) 2007204, Registration No.: State prescription H20041829. The product is a stable suspension of carbon particles with a diameter of 150 nm.2. 2.Preoperative injection method: The preoperative subgroup was injected with carbon nanoparticles 2-6 hours before surgery, with the patient in the position of padded shoulder, and disinfection around the puncture point was prepared prior to the injection of carbon nanoparticles. Under ultrasound guidance, a fine needle was used to puncture the lower 1/3 of the ventral surface, and no blood was detected on aspiration, i.e., 0.1 mL of carbon nanoparticles was injected into each of the 2 sites of each gland, and the total volume of carbon nanoparticles injected was 0.4 mL, and the depth of injection was approximately within the upper third of the gland.
Active Comparator: Intraoperative Injection During Total Thyroidectomy Group
Patients in this group will undergo total thyroidectomy and intraoperative injection of carbon nanoparticles.
Drug: Intraoperative Injection of Carbon Nanoparticles
Intraoperative injection of carbon nanoparticles: After exposing the thyroid peritoneum, 0.1 mL of carbon nanoparticles was injected into both sides of normal thyroid tissue using a syringe (1 mL). Two spots were needed for each flap, and the total volume of injected carbon nanoparticles was 0.4 mL. Finally, the needle was gently backed up under negative pressure to prevent the leakage of carbon nanoparticles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: up to three years
The height indicator will summarize the data in "meters".
up to three years
Weight
Time Frame: up to three years
The weight indicator will summarize data in "kilograms".
up to three years
Genders
Time Frame: up to three years
Data will be summarized in terms of "male" and "female" as units of measurement.
up to three years
BMI
Time Frame: up to three years
BMI will be summarized in "kg/m^2".
up to three years
Tumor Diameter Size
Time Frame: up to three years
Tumor diameter size will be summarized in "millimeters".
up to three years
age
Time Frame: up to three years
Age will be aggregated using "years" as the unit of measurement.
up to three years
Tumor Location
Time Frame: up to three years
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multifocal" as units of measurement.
up to three years
Pathological Results
Time Frame: up to three years
Data will be summarized in terms of detailed pathological results and "none" .
up to three years
Preoperative Serum Calcium
Time Frame: up to three years
The Calcium indicator will summarize data in "mmol/L".
up to three years
Preoperative Serum Thyroid Hormone
Time Frame: up to three years
The thyroid hormone indicator will summarize data in "pmol/L".
up to three years
Preoperative Serum Parathyroid Hormone
Time Frame: up to three years
The parathyroid hormone will summarize data in "pmol/L".
up to three years
Preoperative serum TSH
Time Frame: up to three years
The TSH indicator will summarize data in "mlU/L".
up to three years
Preoperative Vocal Cord Movement Problems or Laryngoscopy Result
Time Frame: up to three years
Data will be summarized in terms of "normal" , "symptomatic" and "laryngoscopy abnormal" as units of measurement.
up to three years
Carbon Nanoparticles Injection Site
Time Frame: up to three years
Data will be summarized in terms of "Upper pole of left lobe" , "middle pole of left lobe" , "lower pole of left lobe" , "upper pole of right lobe" , "middle pole of right lobe" , "lower pole of right lobe" , "isthmus" and "multi-site injection" as units of measurement.
up to three years
Number of Carbon Nanoparticles Injections
Time Frame: up to three years
Number of Carbon Nanoparticles Injections
up to three years
Carbon Nanoparticles Injection Dose
Time Frame: up to three years
Injection dose will be summarized in "milliliter".
up to three years
Duration of The Operation
Time Frame: up to three years
The duration of the operation will summarize data in "h". The time interval from the induction of anesthesia to the end of surgery was selected as the length of surgery, according to the surgical care records
up to three years
Number of Lymph Node Dissection
Time Frame: up to three years
Record the total number of lymph nodes dissected, the number of lymph nodes dissected in the central region, the number of lymph nodes dissected in the lateral cervical region and the number of metastatic lymph nodes detected.
up to three years
Intraoperative Hemorrhage
Time Frame: up to three years
The intraoperative hemorrhage will summarize data in "milliliter".
up to three years
Thyroid Staining
Time Frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The stained thyroid is good in the center and at the margins, with clear staining at the edges; B.The stained thyroid gland has good central staining, and the margins are grossly stained, so that the marginal pattern can be roughly observed; C.The stained thyroid stains well, with poorly stained margins;
up to three years
Lymph node staining
Time Frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.The center and margins of the stained lymph nodes are well stained, and the margins are clearly stained; B. The stained lymph nodes have good central staining and grossly stained margins; the marginal pattern can be roughly observed, and the lymph nodes are definite on palpation; C.Good central staining of the stained lymph nodes, unclear staining of the margins, and precise palpation of the lymph nodes.
up to three years
Parathyroid Glands Staining
Time Frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.Good central infiltration, uniform and clear staining throughout the gland; B.Central infiltration is good, staining of the entire gland is still uniform, but flaky stained areas are seen, and the gland is exact on palpation; C.Central infiltration is fair, staining of the entire gland is stellate with no obvious shape, and the gland is exact on palpation.
up to three years
Nanocarbon Leakage
Time Frame: up to three years
Data will be summarized in terms of "A" ,"B" and "C" as units of measurement. A.no visible leakage, only slight leakage at the injection site, not affecting the parathyroid glands or the recurrent laryngeal nerve; B.leakage is present and visible to the naked eye, but less than 1/2 of the entire operative field, with staining of the trachea, thyroid peritoneum, and anterior cervical musculature; C.Leakage is present and reaches 1/2 of the entire operative field or Carbon Nanoparticles results in staining of the parathyroid glands or the recurrent laryngeal nerve, affecting identification.
up to three years
Duration of Postoperative Pain
Time Frame: up to three years
The duration of postoperative pain will summarize data in "days".
up to three years
Postoperative Drainage
Time Frame: up to three years
The postoperative drainage will summarize data in "milliliter".
up to three years
Length of Postoperative Hospitalization
Time Frame: up to three years
The length of postoperative hospitalization will summarize data in "days"
up to three years
Postoperative Serum Parathyroid Hormone
Time Frame: up to three years
The parathyroid hormone will summarize data in "pmol/L".
up to three years
Numbness of The Hands and Feet
Time Frame: up to three years
The numbness of the hands and feet will be summarized with a "yes" or "no" to the data.
up to three years
Postoperative Laryngeal Recurrent Nerve Irritation and Injury
Time Frame: up to three years
Postoperative laryngeal recurrent nerve irritation and injury will be summarized with a "yes" or "no" to the data.
up to three years
Postoperative Hematoma
Time Frame: up to three years
The postoperative hematoma will be summarized with a "yes" or "no" to the data.
up to three years
Postoperative Tracheocutaneous Fistula
Time Frame: up to three years
The postoperative tracheocutaneous fistula will be summarized with a "yes" or "no" to the data.
up to three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • nanoc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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