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

NCT06124469 | Completed

• 1 other identifier: 3
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer; Lymph Node

Keywords

Lymph node; Thyroid cancer; Ultrasonography; Metastasis

Outcome Measures

Primary Outcomes (1)

• metastatic lymph node

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

  All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.

Study Arms (2)

Benign lymph nodes

Categories UNN-RADS 1 and 2 (test negative)

Diagnostic Test: US-guided fine needle aspiration (FNA)

Metastatic lymph nodes

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

Diagnostic Test: US-guided fine needle aspiration (FNA)

Interventions

US-guided fine needle aspiration (FNA) DIAGNOSTIC_TEST

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

Benign lymph nodes; Metastatic lymph nodes

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes at Unidad Médica de Alta Especialidad HE 1 CMN Bajío

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Unidad Medica de Alta Especialidad No. 1, Bajío

León, Guanajuato, 37260,, Mexico

Location

Related Publications (6)

• Ryu KH, Lee KH, Ryu J, Baek HJ, Kim SJ, Jung HK, Kim SM. Cervical Lymph Node Imaging Reporting and Data System for Ultrasound of Cervical Lymphadenopathy: A Pilot Study. AJR Am J Roentgenol. 2016 Jun;206(6):1286-91. doi: 10.2214/AJR.15.15381. Epub 2016 Apr 12.

  PMID: 27070179 RESULT

• Ahuja AT, Ying M. Sonographic evaluation of cervical lymph nodes. AJR Am J Roentgenol. 2005 May;184(5):1691-9. doi: 10.2214/ajr.184.5.01841691.

  PMID: 15855141 RESULT

• Prativadi R, Dahiya N, Kamaya A, Bhatt S. Chapter 5 Ultrasound Characteristics of Benign vs Malignant Cervical Lymph Nodes. Semin Ultrasound CT MR. 2017 Oct;38(5):506-515. doi: 10.1053/j.sult.2017.05.005. Epub 2017 May 20.

  PMID: 29031367 RESULT

• Ni X, Xu S, Zhan W, Zhou W. Ultrasonographic features of cervical lymph node metastases from medullary thyroid cancer: a retrospective study. BMC Med Imaging. 2022 Aug 29;22(1):151. doi: 10.1186/s12880-022-00882-7.

  PMID: 36038830 RESULT

• Meyer JE, Steffen A, Bienemann M, Hedderich J, Schulz U, Laudien M, Quetz J, Wollenberg B. Evaluation and development of a predictive model for ultrasound-guided investigation of neck metastases. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):315-20. doi: 10.1007/s00405-011-1611-1. Epub 2011 May 6.

  PMID: 21547389 RESULT

• Sarda Inman ED, Valdez Rojas AM. Ultrasound Neck Node Reporting and Data System (UNN-RADS) for lymphadenopathy: A structured report. J Mex Fed Radiol Imaging 2022;3:151-163.

  RESULT

MeSH Terms

Conditions

Thyroid Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilda Maciaqs, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 21 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: March 15, 2022
• Primary Completion: October 23, 2023
• Study Completion: November 1, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 month

Locations

ME (1)