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NCT Number: NCT06527027

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

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.

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Key information

Conditions

Lymph Node Neoplasm Disease Attributes Hemic and Lymphatic Diseases Lymph Node Metastasis Lymphadenopathy Lymphatic Diseases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute, Krakow, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed or suspected cancer,
  • planned lymph node biopsy or lymphadenectomy,
  • planned or performed CT/MRI covering an area of the body with lymph nodes, - verified histopathologically or cytologically,
  • informed consent to participate in the study.

Exclusion criteria

  • non-diagnostic CT/MRI images of lymph nodes due to reasons such as movement artifacts, artifacts from metal elements and any other factors that do not allow for proper assessment of the nodes,
  • inconclusive histopathological or cytological results, which do not allow the nodes to be classified into one of two groups - benign or malignant.

Treatment and study plan

Lymph node assessment according to RECIST 1.1 in CT

Other

RECIST 1.1 classifies lymph nodes as healthy when they have a short axis dimension (SAD) of <10 mm; Nodes with a SAD dimension >=10 mm are considered to be involved in the cancer process.

Lymph node assessment according to Node-RADS in CT

Other

Node-RADS classifies lymph nodes taking into account parameters such as: size, degree of homogeneity, boundaries and shape of the node. Depending on the degree of change in a given parameter, an appropriate number of points are awarded in each category, and the sum of the points determines the final classification of the node into one of five categories of probability of being affected by a cancer process: 1-very low, 2-low, 3-medium, 4 -high, 5-very high.

Lymph node assessment according to LN-RADS in CT

Other

LN-RADS (Lymph Node Reporting and Data System) categorizes nodes according to a scale that reflects the radiological and clinical forms of the nodes and the level of probability of a malignant process:

LN-RADS 1 - normal lymph node LN-RADS 2 - enlarged and fatty lymph node, not suspected from an oncological point of view LN-RADS 3 - lymph node with features suggesting reactive changes. LN-RADS 4a - lymph node with slight oncological suspicion LN-RADS 4b - lymph node with strong oncological suspicion LN-RADS 5 - definitely cancerous node

Lymph node assessment according to RECIST 1.1 in MRI

Other

RECIST 1.1 classifies lymph nodes as healthy when they have a short axis dimension (SAD) of <10 mm; Nodes with a SAD dimension >=10 mm are considered to be involved in the cancer process.

Lymph node assessment according to Node-RADS in MRI

Other

Node-RADS classifies lymph nodes taking into account parameters such as: size, degree of homogeneity, boundaries and shape of the node. Depending on the degree of change in a given parameter, an appropriate number of points are awarded in each category, and the sum of the points determines the final classification of the node into one of five categories of probability of being affected by a cancer process: 1-very low, 2-low, 3-medium, 4 -high, 5-very high.

Lymph node assessment according to LN-RADS in MRI

Other

LN-RADS (Lymph Node Reporting and Data System) categorizes nodes according to a scale that reflects the radiological and clinical forms of the nodes and the level of probability of a malignant process:

LN-RADS 1 - normal lymph node LN-RADS 2 - enlarged and fatty lymph node, not suspected from an oncological point of view LN-RADS 3 - lymph node with features suggesting reactive changes. LN-RADS 4a - lymph node with slight oncological suspicion LN-RADS 4b - lymph node with strong oncological suspicion LN-RADS 5 - definitely cancerous node

Primary outcomes

  1. The effectiveness of assessment of LN-RADS, Node-RADS and RECIST 1.1

    Time frame: After accomplished lymph node assessment according to classification system (up to 1 year)

    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).

Secondary outcomes

  1. Quantification of the agreement between raters assessing according to the specific classification system

    Time frame: After accomplished lymph node assessment according to classification system (up to 1 year)

    Estimation of the level of agreement between investigators in individual lymph node staging systems.

  2. The predictive value of various morphological parameters of lymph nodes regarding in context of clinical characteristics

    Time frame: After accomplished lymph node assessment according to classification system (up to 1 year)

    Assessment of the predictive value of various morphological parameters of lymph nodes and clinical information in the context of differentiating benign and cancerous nodes.

Study contacts

Contact information is provided by the study sponsor or research team.

Cezary Chudobiński, PhD

CONTACT

[email protected]

+4842 689 58 99

Sponsors and collaborators

Lead sponsor

Copernicus Memorial Hospital

Other

Collaborators

  • Medical Research Agency, Poland

Registry information

Official study title

Comparison of the LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes in MRI and CT in Relation to Histopathological Results - a Prospective, Randomised Study

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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