Comparison of LN-RADS, RECIST 1.1, and Node-RADS for Lymph Node Assessment in MRI and CT with Histopathological Correlation: A Prospective Randomized Study

What this Trial Is About

Researchers are evaluating new ways to classify lymph nodes using LN-RADS scales in CT and MRI scans, comparing this method with two other systems called RECIST 1.1 and Node-RADS. The goal is to improve the detection of cancerous changes in lymph nodes, which are vital for diagnosis and treatment in oncology. Current methods, especially RECIST 1.1, have a high error rate and may miss small metastases, leading to under-treatment and increased risk of cancer recurrence. The study compares three lymph node assessment methods: LN-RADS, Node-RADS, and RECIST 1.1. LN-RADS categorizes nodes based on their radiological and clinical features, including small metastases about 3 mm in size. Node-RADS uses a scoring system based on size, homogeneity, boundaries, and shape of the lymph nodes. RECIST 1.1 relies mainly on lymph node size, with nodes smaller than 10 mm considered healthy. These assessments are performed using CT and MRI scans and are randomized and double-blinded. Participants diagnosed or suspected of having cancer will undergo planned lymph node biopsy or removal and CT/MRI scans covering lymph nodes. Researchers will compare the effectiveness of each classification system by analyzing lymph node assessments against histopathological results over up to one year. They will also measure agreement between raters and evaluate how different lymph node features predict clinical outcomes. The study includes safety monitoring and lasts up to one year after lymph node assessment.

LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes