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

December 21, 2025 updated by: Cezary Chudoniński, Copernicus Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Krakow, Poland
        • Active, not recruiting
        • Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute
      • Lodz, Poland, 93-513
        • Recruiting
        • Copernicus Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Cezary Chudobiński, PhD
      • Lodz, Poland
        • Active, not recruiting
        • Independent Public Healthcare Centre (SPZOZ) , University Clinical Hospital No. 2 of the Medical University of Łódź
      • Warsaw, Poland
        • Active, not recruiting
        • Doradztwo i Zarządzanie w Opiece Zdrowotnej A.K. Sp.z o.o
      • Warsaw, Poland
        • Active, not recruiting
        • Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute
      • Warsaw, Poland
        • Active, not recruiting
        • Professor Orłowski Hospital in Warsaw , Independent Public Healthcare Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Lymph node assessment according to RECIST 1.1
Other: Lymph node assessment according to RECIST 1.1 in CT
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.
Other: Lymph node assessment according to RECIST 1.1 in MRI
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.
Experimental: Lymph node assessment according to LN-RADS
Other: Lymph node assessment according to LN-RADS in CT

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

Other: Lymph node assessment according to LN-RADS in MRI

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
Experimental: Lymph node assessment according to Node-RADS
Other: Lymph node assessment according to Node-RADS in CT
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.
Other: Lymph node assessment according to Node-RADS in MRI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
After accomplished lymph node assessment according to classification system (up to 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
After accomplished lymph node assessment according to classification system (up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copernicus Memorial Hospital

Collaborators

Medical Research Agency, Poland

Investigators

  • Principal Investigator: Cezary Chudobiński, PhD, Copernicus Memoriał Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 27, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/ABM/03/00027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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