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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01089335
First received: March 16, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Region Skane:

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) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089335

Contacts
Contact: Anders Bergenfelz, MD, PhD + 46 46 17 20 86 anders.bergenfelz@med.lu.se
Contact: Erik Nordenström, MD, PhD + 46 46 17 23 05 erik.nordenstrom@skane.se

Locations
Sweden
Department of Surgery and Department of Imaging, Skåne University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Anders OJ Bergenfelz, MD, PhD    + 46 46 17 20 86    anders.bergenfelz@med.lu.se   
Contact: Erik Nordenström, MD, PhD    + 46 46 17 23 05    erik.nordenstrom@skane.se   
Sub-Investigator: Martin Almqvist, MD, PhD         
Sub-Investigator: Helene Almquist, MD, PhD         
Sub-Investigator: Zoran Mijovic, MD         
Sub-Investigator: Julian Willner, MD         
Sub-Investigator: Erik Nordenström, MD, PhD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Anders Bergenfelz, MD, PhD Department of Surgery, Skåne University Hospital, Lund
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01089335     History of Changes
Other Study ID Numbers: 2009/71
Study First Received: March 16, 2010
Last Updated: July 5, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Sentinel node
Thyroid cancer
Thyroid neoplasia
Follicular neoplasia

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Neoplasms
Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 16, 2014