Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-28 @ 8:23 AM
Study NCT ID:
NCT01089335
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2010-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Lymphnode in Patients With Papillary Thyroid Carcinoma and in Patients With Suspected Thyroid Neoplasia
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Sentinel Node Investigation in Patients With Highly Differentiated Papillary Thyroid Carcinoma and in Patients With Thyroid Neoplasia of Unclear Malignant Potential
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNTC
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: