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

RecruitingNAAges 18 Years - anyAllCopernicus Memorial Hospital
NCT06527027 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lymph node assessment according to RECIST 1.1 in CT
  • Lymph node assessment according to Node-RADS in CT
  • Lymph node assessment according to LN-RADS in CT
  • Lymph node assessment according to RECIST 1.1 in MRI
  • Lymph node assessment according to Node-RADS in MRI
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Where

6 sites
Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute
Krakow, Poland
Copernicus Memorial Hospital
Lodz, Poland
Independent Public Healthcare Centre (SPZOZ) , University Clinical Hospital No. 2 of the Medical University of Łódź
Lodz, Poland
Doradztwo i Zarządzanie w Opiece Zdrowotnej A.K. Sp.z o.o
Warsaw, Poland
Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute
Warsaw, Poland
Professor Orłowski Hospital in Warsaw , Independent Public Healthcare Centre
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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