An interventional study of Lymph node assessment according to RECIST 1.1 in CT and Lymph node assessment according to Node-RADS in CT in Lymph Node Neoplasm and Lymph Node Metastasis, sponsored by Copernicus Memorial Hospital. Recruiting at 6 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Copernicus Memorial Hospital · Not applicable, Interventional, and Diagnostic
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.
213 studies on the registry are indexed under Lymphatic Metastasis; 77 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 97 across 109 interventional studies indexed under Lymphatic Metastasis.
Browse Lymphatic Metastasis studies →Copernicus Memorial Hospital is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Lymph node assessment according to RECIST 1.1 in CT · Other: Lymph node assessment according to RECIST 1.1 in MRI
Other: Lymph node assessment according to LN-RADS in CT · Other: Lymph node assessment according to LN-RADS in MRI
Other: Lymph node assessment according to Node-RADS in CT · Other: Lymph node assessment according to Node-RADS 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.
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.
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
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.
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.
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
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).
Time frame: After accomplished lymph node assessment according to classification system (up to 1 year)
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.
Time frame: 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.
Time frame: After accomplished lymph node assessment according to classification system (up to 1 year)
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