Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer

March 25, 2016 updated by: Wenbin Yu, Peking University Cancer Hospital & Institute

Papillary thyroid cancer (PTC) is the most common subtype of thyroid cancer.

The most common site of PTC nodal metastases is the central neck, which has a reported rate of lymph node metastases as high as 50%~70%.

Central neck dissection has important value to ensure accurate clinical staging and surgical planning.

As a novel lymphatic tracer, carbon nanoparticles (CN) have been applied successfully in the detection of sentinel lymph nodes in breast and gastric cancers, while not been used as a lymphatic tracer for PTC. The goal of this study was to evaluate whether the use of CN facilitates the detection of lymph nodes, increases the number of metastatic lymph nodes removed, accurately reflects the metastatic condition of the central neck, and has the potential to protect the parathyroid glands.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thyroid cancer is the most common endocrine malignancy. It is estimated that 96% of all new endocrine organ cancers will originate from the thyroid gland, resulting in approximately 63,000 new cases in 2014 in the US1. Among them, papillary thyroid cancer (PTC) is the most common subtype of thyroid cancer, accounting for more than 90% of all thyroid cancers. The incidence of PTC has been increasing in recent years, largely because of advances in early detection with ultrasonography and fine-needle aspiration biopsy1-4. The most effective treatment for PTC is the complete removal of the primary tumor and the metastatic regional lymph nodes, which is a prerequisite for other adjuvant therapies. Cervical lymph node metastases are quite common in PTC and have been reported to occur in 12-81% of patients with PTC5. The most common site of PTC nodal metastases is the central neck, which has a reported rate of lymph node metastases as high as 50%~70%5. Lymph node metastases in this area are difficult to identify preoperatively because the lymph nodes typically do not appear abnormal on preoperative imaging6,7.

Routine dissection of the central neck compartment is still controversial due to uncertain prognostic value of preserving clinically non-apparent lymph node metastasis1,8, central neck dissection has important value to ensure accurate clinical staging and surgical planning. According to previously published data, prophylactic central dissection has been suggested to improve disease-specific survival and to decrease local recurrence9,10 as well as post-treatment thyroglobulin levels9,11. Neck dissection also informs postoperative treatment, follow-up programs, assessment of recurrence risk, and prognosis12. However, routine neck dissection is controversial because of the uncertain effect on prognosis of clinically non-apparent lymph node metastases and because of complications, such as damage to the parathyroid glands, hypoparathyroidism, temporary/permanent recurrent laryngeal nerve injury, and tracheal or esophageal injury, that may profoundly influence a patient's qual¬ity of life.

Methylene blue has been used in the detection of sentinel lymph nodes in thyroid cancer, but methylene blue can also stain parathyroid glands, thyroid tissue, and fat, which can make the anatomic boundaries unclear and thereby restrict the use of methylene blue in PTC. As a novel lymphatic tracer13,14, carbon nanoparticles (CN) have been applied successfully in the detection of sentinel lymph nodes in breast and gastric cancers, while not been used as a lymphatic tracer for PTC. Thus, investigators hypothesized that CN may have clinical value in thyroid cancer as a novel lymph node tracer to guide central neck dissection. The goal of this study was to evaluate whether the use of CN facilitates the detection of lymph nodes, increases the number of metastatic lymph nodes removed, accurately reflects the metastatic condition of the central neck, and has the potential to protect the parathyroid glands. In this study, investigators evaluated the clinical value of CN in acquiring a more accurate reflection of the central neck lymph node status and in guiding central neck dissection.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients were diagnosed with PTC by preoperative fine needle aspiration cytology,
  • Underwent the initial operation in our department, and had all tumors located in one lobe.
  • PTC with a tumor between 1 and 4 cm

Exclusion Criteria:

  • Nonthyroid cancer,
  • Previous thyroid or parathyroid surgery
  • Preoperative hypoparathyroidism or hypocalcemia
  • Pregnancy or lactation
  • Presence or suspicion of lateral neck lymph node metastasis,
  • Age under 18 years
  • Noncompliance with the follow-up protocol

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carbon nanoparticles
0.1 ml of CN suspension was injected per spot into the tissue surrounding the tumor using a skin test syringe. Two or three randomly selected spots were injected slowly for each tumor, and the total amount injected was no more than 0.5 mL per lobe.
Drug: carbon nanoparticles
0.1 ml of CN suspension was injected per spot into the tissue surrounding the tumor using a skin test syringe. Two or three randomly selected spots were injected slowly for each tumor, and the total amount injected was no more than 0.5 mL per lobe.
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lymph node metastatic rates between the carbon nanoparticles and control group
Time Frame: one year
one year
total dissected lymph nodes less than 5mm between the carbon nanoparticles and control group
Time Frame: one year
one year
the number of metastatic lymph nodes with diameter < 5mm between the carbon nanoparticles and control group
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Chair: Wenbin Yu, MD, Department of head neck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJ20161206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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