Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia (SNTC)

• ClinicalTrials.gov Identifier: NCT01089335
• Recruitment Status: Completed
• First Posted: March 18, 2010
• Last Update Posted: March 28, 2019
• Sponsor: Region Skane
• Information provided by (Responsible Party): Region Skane

Study Description

Brief Summary:

The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.

The study investigates if the sentinel lymphnode (SN)

• Reliably (with high sensitivity and specificity), can predict the pathological findings of the lymphnodes in the central compartment in patients with highly differentiated papillary thyroid cancer
• Is useful to aid in the final diagnosis and staging of thyroid neoplasias of unclear malignant potential, and could be used to select patients for further central lymphnode revision.

Condition or disease	Intervention/treatment
Thyroid Neoplasms; Thyroid Cancer	Procedure: Histological investigation of the SN

Detailed Description:

The standard surgical treatment for highly differentiated papillary thyroid cancer > 10 mm according to recent national and international guidelines, is total thyroidectomy and central lymphnode clearance, and for patients with cytology indicating thyroid neoplasia of unclear malignant potential hemithyroidectomy on the side of the tumour.

There are however a number of clinical problems with these approaches:

• For patients with papillary thyroid cancer, a significant proportion will receive unnecessary extensive surgical treatment
• In papillary thyroid cancer, central lymphnode clearance increases the risk for complications, especially the risk for hypoparathyroidism.

According to a Scandinavian survey (Scandinavian Quality Register for Thyroid- and Parathyroid Surgery; www. thyroid-parathyroidsurgery.com),16 % of patients with unclear follicular neoplasia, will have a final histological diagnosis of thyroid cancer, and in half of them, this cancer will be of the papillary subtype. In patients with preoperatively suspected, but not proven malignancy by cytology, 30 % will receive a final histological diagnosis of thyroid cancer, and in these patients, 70 % will be of the papillary subtype. Typically these patients will undergo a second operation with a contralateral hemithyroidectomy. In many cases, due to risk for complications, central lymphnode clearance is avoided in these cases. Therefore, the staging of the cancer will be incomplete, and some patients will receive suboptimal surgical treatment.

The study is designed to compare SN investigation with the final histology of the central lymphnodes:

• Pretracheal and bilateral paratracheal for patients with preoperatively diagnosed papillary thyroid cancer
• Pretracheal and ipsilateral paratracheal for tumours of uncertain malignant potential on cytology

The identification of SN will be aided by preoperative ultrasound guided injection of 99m- Tc- nanocolloid albumin in the thyroid tumour. The results of the histological investigation of SN will be compared to that of the results from the central lymphnode clearance.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sentinel Node Investigation in Patients With Highly Differentiated Papillary Thyroid Carcinoma and in Patients With Thyroid Neoplasia of Unclear Malignant Potential
• Study Start Date: March 2010
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: December 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Papillary thyroid cancer; Patients with preoperatively diagnosed highly differentiated papillary thyroid cancer	Procedure: Histological investigation of the SN; 99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.
Tumour of uncertain malignant potential; Thyroid tumours with preoperative cytology indicating follicular neoplasia, or on cytology suspected but not proven malignancy	Procedure: Histological investigation of the SN; 99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.

Outcome Measures

Primary Outcome Measures :

1. Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis) [ Time Frame: 14 days ]
   The histological investigation of the sentinel lymph node(s) (recorded as metastasis or no metastasis), will be compared to the definitive histological investigation of the non SN central lymphnodes (metastasis or no metastasis), cleared by surgery. Sensitivity and specificity of the histological SN investigation to predict the histological outcome of the non SN central lymphnodes (metastasis or no metastasis), will be calculated.

Secondary Outcome Measures :

1. Sensitivity of 99mTc-nanocolloid albumin in the diagnosis of a sentinel lymphnode [ Time Frame: 1 day ]
   99mTc-nanocolloid albumin will be injected under guidence by ultrasonography. The sensitivity to detect a SN on preoperative imaging (detected SN on imaging/total number of investigations) and during surgery by a collimated probe for SN mapping(SN detected/total number of operations), will be calculated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

- Patients diagnosed and operated for papillary thyroid cancer > 10 mm at the Department of Surgery, Skåne University Hospital, Lund, Sweden

_ Patients with diagnosed and operated for a thyroid tumour of unclear malignant potential at the Department of Surgery, Skåne University Hospital, Lund, Sweden

Criteria

Inclusion Criteria:

• Patients with first time surgery for proven papillary thyroid cancer > 10 mm
• Patients with first time surgery for a cytologic diagnosis of follicular neoplasia or suspected (not proven) malignancy

Exclusion Criteria:

• Age below 18 years
• Pregnancy or lactation
• Inability to understand written and oral information or to comply with scheduled follow-up

Contacts and Locations

Locations

Sweden

Department of Surgery and Department of Imaging, Skåne University Hospital

Lund, Sweden, 221 85

Sponsors and Collaborators

Region Skane

Investigators

• Principal Investigator: Anders Bergenfelz, MD, PhD; Department of Surgery, Skåne University Hospital, Lund

More Information

• Responsible Party: Region Skane
• ClinicalTrials.gov Identifier: NCT01089335
• Other Study ID Numbers: 2009/71
• First Posted: March 18, 2010
• Last Update Posted: March 28, 2019
• Last Verified: March 2019

Keywords provided by Region Skane:

Sentinel node; Thyroid cancer; Thyroid neoplasia; Follicular neoplasia

Additional relevant MeSH terms:

Thyroid Neoplasms; Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Adenocarcinoma