Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Study type: Interventional

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.
    

Intervention name(s): carbon nanoparticles
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): normal saline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment