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

NCT01089335 | Completed

• 1 other identifier: 2009/71
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasms; Thyroid Cancer

Keywords

Sentinel node; Thyroid cancer; Thyroid neoplasia; Follicular neoplasia

Outcome Measures

Primary Outcomes (1)

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

  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.

  14 days

Secondary Outcomes (1)

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

  1 day

Study Arms (2)

Papillary thyroid cancer

Patients with preoperatively diagnosed highly differentiated papillary thyroid cancer

Procedure: Histological investigation of the SN

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

Interventions

Histological investigation of the SN PROCEDURE

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.

Papillary thyroid cancer; Tumour of uncertain malignant potential

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Surgery and Department of Imaging, Skåne University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Anders Bergenfelz, MD, PhD

  Department of Surgery, Skåne University Hospital, Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 18, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

SE (1)