NCT02724176

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

March 18, 2016

Last Update Submit

March 25, 2016

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (3)

  • lymph node metastatic rates between the carbon nanoparticles and control group

    one year

  • total dissected lymph nodes less than 5mm between the carbon nanoparticles and control group

    one year

  • the number of metastatic lymph nodes with diameter < 5mm between the carbon nanoparticles and control group

    one year

Study Arms (1)

carbon nanoparticles

EXPERIMENTAL

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

Interventions

carbon nanoparticlesDRUG

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.

Also known as: normal saline
carbon nanoparticles

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24163324BACKGROUND

  • 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.

    PMID: 22521260RESULT

  • 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.

    PMID: 23155345RESULT

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Wenbin Yu, MD

    Department of head neck

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of head neck

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 31, 2016

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share