Clinical trial NCT06124469: UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Lymph Node
Keywords: Lymph node
Thyroid cancer
Ultrasonography
Metastasis
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2023-11-09
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: metastatic lymph node
timeFrame: All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Unidad Medica de Alta Especialidad No. 1, Bajío
state: Guanajuato
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Hilda Maciaqs, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.