Thyroid CancerNCT02724176
Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
A study testing carbon nanoparticles in people with Thyroid Cancer, run by Peking University Cancer Hospital & Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- carbon nanoparticles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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%.
Read more
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.
Read the 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.
- Conditions
- Thyroid Cancer
- Being tested
- carbon nanoparticles
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon nanoparticlesDrug
Also called normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: carbon nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymph node metastatic rates between the carbon nanoparticles and control group
Measured: one year
total dissected lymph nodes less than 5mm between the carbon nanoparticles and control group
Measured: one year
the number of metastatic lymph nodes with diameter < 5mm between the carbon nanoparticles and control group
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Yu, Peking University Cancer Hospital & Institute
- Investigators
- Wenbin Yu, MD, Study chair, Department of head neck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724176
- Sponsor's protocol ID
- BJ20161206
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24163324Hao 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.
PubMed 22521260Cai 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.
PubMed 23155345
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role for Carbon Nanoparticles to Guide Central Neck Dissection in Patients With Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02724176
- Acronym / sponsor ID
- BJ20161206
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carbon nanoparticles | Experimental | Drug: carbon nanoparticles0.1 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Nonthyroid cancer,
- Previous thyroid or parathyroid surgery
- Preoperative hypoparathyroidism or hypocalcemia
- Pregnancy or lactation
- Presence or suspicion of lateral neck lymph node metastasis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon nanoparticlesAlso: normal saline0.1 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 |
Primary outcome
lymph node metastatic rates between the carbon nanoparticles and control group
Time frame: one year
total dissected lymph nodes less than 5mm between the carbon nanoparticles and control group
Time frame: one year
the number of metastatic lymph nodes with diameter < 5mm between the carbon nanoparticles and control group
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Background: PubMed 24163324Huang 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 publication: PubMed 22521260Hao 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 publication: PubMed 23155345Cai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbin Yu, MD study chair
Department of head neck
Questions about this trial
What is this clinical trial studying?
A study testing carbon nanoparticles in people with Thyroid Cancer, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lymph node metastatic rates between the carbon nanoparticles and control group (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724176, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.