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

NCT01089335 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-03-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Anders Bergenfelz, MD, PhD · Department of Surgery, Skåne University Hospital, Lund

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089335 on ClinicalTrials.gov