NCT06124469

UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer

Validation of The Ultrasound Neck Node Reporting and Data System (UNN-RADS) Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.

Detailed description

This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded. UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.

Conditions

• Thyroid Cancer
• Lymph Node

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	US-guided fine needle aspiration (FNA)	This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-10-23
• Completion: 2023-11-01
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: Mexico