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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
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 18, 2016
    Last Updated
    March 25, 2016
    Sponsor
    Peking University Cancer Hospital & Institute
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    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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