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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT01089335

Collaborator

(none)

100

Enrollment

Location

105

Duration (Months)

Patients Per Site Per Month

Study Details

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	Phase
Thyroid Neoplasms Thyroid Cancer	Procedure: Histological investigation of the SN

Detailed Description

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 :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of SN histology compared with the final histology of the non SN central lymph nodes (metastasis or no metastasis) [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

Sensitivity of 99mTc-nanocolloid albumin in the diagnosis of a sentinel lymphnode [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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