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

Sponsor
Instituto Mexicano del Seguro Social (Other)
Overall Status
Completed
CT.gov ID
NCT06124469
Collaborator
(none)
99
1
19.6
5.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: US-guided fine needle aspiration (FNA)

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
99 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
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
Actual Study Start Date :
Mar 15, 2022
Actual Primary Completion Date :
Oct 23, 2023
Actual Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Benign lymph nodes

Categories UNN-RADS 1 and 2 (test negative)

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

Metastatic lymph nodes

Categories UNN-RADS 3, 4, and 5 (test positive).

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

Outcome Measures

Primary Outcome Measures

  1. metastatic lymph node [All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.]

    Fine needle aspiration biopsy (FNA) results were the gold standard (metastatic or benign).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1
Exclusion Criteria:
    1. underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unidad Medica de Alta Especialidad No. 1, Bajío Leon Guanajuato Mexico 37260,

Sponsors and Collaborators

  • Instituto Mexicano del Seguro Social

Investigators

  • Study Chair: Hilda Maciaqs, PhD, Instituto Mexicano del Seguro Social

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hilda Elizabeth Macías Cervantes, PhD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT06124469
Other Study ID Numbers:
  • 3
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hilda Elizabeth Macías Cervantes, PhD, Instituto Mexicano del Seguro Social
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2023