LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes
NCT Number: NCT06527027
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lymph Node Neoplasm|Lymph Node Metastasis
Interventions: OTHER: Lymph node assessment according to RECIST 1.1 in CT|OTHER: Lymph node assessment according to Node-RADS in CT|OTHER: Lymph node assessment according to LN-RADS in CT|OTHER: Lymph node assessment according to RECIST 1.1 in MRI|OTHER: Lymph node assessment according to Node-RADS in MRI|OTHER: Lymph node assessment according to LN-RADS in MRI
Sponsor: Copernicus Memorial Hospital
Collaborators: Medical Research Agency, Poland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-12-01
Completion Date: 2028-12-31
Locations: Copernicus Memorial Hospital, Łódź, 93-513, Poland

Summary:
The project aims to evaluate the value of the new LN-RADS scales for lymph node classification in CT and MR and to compare this method with two other methods RECIST 1.1 and Node-RADS.

The main tested system in the study is LN-RADS, the comparators are RECIST 1.1 and Node-RADS criteria.

Lymph nodes are a key diagnostic and therapeutic element in oncology. Despite the technological progress, the detection of neoplastic changes in the lymph nodes is of low effectiveness, which results from the imperfection of the criteria used. Currently, the most widely used criterion is the RECIST 1.1 guideline developed in the 1990s, according to which the lymph node dimension in the short axis with a cut-off point of 10 mm is decisive. Lymph nodes smaller than 10 mm across are considered normal. It is a criterion with a high error rate, both due to the false-negative diagnoses (with small metastases below 10 mm) and false-positive diagnoses (in the case of inflammatory lymphadenopathy).

A particular disadvantageous situation is when the metastatic nodes and their transverse dimension is less than 10 mm, because they are treated as healthy nodes and the degree of the disease advancement is underestimated. As a result, the patient is not treated properly - no complete lymphadenectomy, no radiotherapy to the area of these nodes or insufficient systemic treatment. In all cases, underestimating the stage of the neoplastic diseases increases the risk of the recurrence.

LN-RADS accounts small metastases in nodes about 3 mm in size, thus about 20% more metastatic nodes may be detected compared to RECIST 1.1 method. This means that currently, according to RECIST 1.1 rules, approx. 20% of patients have missed nodal metastases and consequently receive insufficient treatment resulting in relapse. Previous studies have shown that RECIST 1.1 shows a high level of underestimation of metastatic nodes. The Node-RADS system, as the second comparator next to RECIT 1.1, is a fairly new system moving towards the structural assessment of lymph nodes, but proposed arbitrarily, without hard evidence for its effectiveness. Despite the publication of the Node-RADS system in a medical journal, it is not validated. The Node-RADS has numerous limitations and weaknesses that reduce its value.

Primary Outcome Measures: The effectiveness of assessment of LN-RADS, Node-RADS and RECIST 1.1, Comparative assessment of the effectiveness of each of the three tested diagnostic methods (LN-RADS, RECIST 1.1, Node-RADS) in the form of an assessment of sensitivity, specificity and predictive value (positive/negative)., After accomplished lymph node assessment according to classification system (up to 1 year)
Secondary Outcome Measures: Quantification of the agreement between raters assessing according to the specific classification system, Estimation of the level of agreement between investigators in individual lymph node staging systems., After accomplished lymph node assessment according to classification system (up to 1 year)|The predictive value of various morphological parameters of lymph nodes regarding in context of clinical characteristics, Assessment of the predictive value of various morphological parameters of lymph nodes and clinical information in the context of differentiating benign and cancerous nodes., After accomplished lymph node assessment according to classification system (up to 1 year)