Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
carbon nanoparticles
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
carbon nanoparticles
Arm Description
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.
Outcomes
Primary Outcome Measures
lymph node metastatic rates between the carbon nanoparticles and control group
total dissected lymph nodes less than 5mm between the carbon nanoparticles and control group
the number of metastatic lymph nodes with diameter < 5mm between the carbon nanoparticles and control group
Secondary Outcome Measures
Full Information
NCT ID
NCT02724176
First Posted
March 18, 2016
Last Updated
March 25, 2016
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT02724176
Brief Title
Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
Official Title
Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
carbon nanoparticles
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
carbon nanoparticles
Other Intervention Name(s)
normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
lymph node metastatic rates between the carbon nanoparticles and control group
Time Frame
one year
Title
total dissected lymph nodes less than 5mm between the carbon nanoparticles and control group
Time Frame
one year
Title
the number of metastatic lymph nodes with diameter < 5mm between the carbon nanoparticles and control group
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbin Yu, MD
Organizational Affiliation
Department of head neck
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24163324
Citation
Huang K, Luo D, Huang M, Long M, Peng X, Li H. Protection of parathyroid function using carbon nanoparticles during thyroid surgery. Otolaryngol Head Neck Surg. 2013 Dec;149(6):845-50. doi: 10.1177/0194599813509779. Epub 2013 Oct 25.
Results Reference
background
PubMed Identifier
22521260
Citation
Hao RT, Chen J, Zhao LH, Liu C, Wang OC, Huang GL, Zhang XH, Zhao J. Sentinel lymph node biopsy using carbon nanoparticles for Chinese patients with papillary thyroid microcarcinoma. Eur J Surg Oncol. 2012 Aug;38(8):718-24. doi: 10.1016/j.ejso.2012.02.001. Epub 2012 Apr 20.
Results Reference
result
PubMed Identifier
23155345
Citation
Cai HK, He HF, Tian W, Zhou MQ, Hu Y, Deng YC. Colorectal cancer lymph node staining by activated carbon nanoparticles suspension in vivo or methylene blue in vitro. World J Gastroenterol. 2012 Nov 14;18(42):6148-54. doi: 10.3748/wjg.v18.i42.6148.
Results Reference
result
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Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
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