Clinical trial NCT06527027: LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymph Node Neoplasm
Lymph Node Metastasis
Keywords: Lymph Nodes
Lymph Node Excision
Tomography, X-ray computed
Lymphadenopathy
Recurrence
Magnetic Resonance Imaging
Lead sponsor: Copernicus Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
First posted: 2024-07-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The effectiveness of assessment of LN-RADS, Node-RADS and RECIST 1.1
timeFrame: After accomplished lymph node assessment according to classification system (up to 1 year)
Secondary outcomes:
measure: Quantification of the agreement between raters assessing according to the specific classification system
timeFrame: After accomplished lymph node assessment according to classification system (up to 1 year)
measure: The predictive value of various morphological parameters of lymph nodes regarding in context of clinical characteristics
timeFrame: After accomplished lymph node assessment according to classification system (up to 1 year)
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Copernicus Memorial Hospital
Study officials:
affiliation: Copernicus Memoriał Hospital
name: Cezary Chudobiński, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsholtz FHJ, Asbach P, Haas M, Becker M, Beets-Tan RGH, Thoeny HC, Padhani AR, Hamm B. Introducing the Node Reporting and Data System 1.0 (Node-RADS): a concept for standardized assessment of lymph nodes in cancer. Eur Radiol. 2021 Aug;31(8):6116-6124. doi: 10.1007/s00330-020-07572-4. Epub 2021 Feb 14.
citation: Prenzel KL, Monig SP, Sinning JM, Baldus SE, Brochhagen HG, Schneider PM, Holscher AH. Lymph node size and metastatic infiltration in non-small cell lung cancer. Chest. 2003 Feb;123(2):463-7. doi: 10.1378/chest.123.2.463.
citation: Yoshimura G, Sakurai T, Oura S, Suzuma T, Tamaki T, Umemura T, Kokawa Y, Yang Q. Evaluation of Axillary Lymph Node Status in Breast Cancer with MRI. Breast Cancer. 1999 Jul 25;6(3):249-258. doi: 10.1007/BF02967179.
citation: Choi YJ, Ko EY, Han BK, Shin JH, Kang SS, Hahn SY. High-resolution ultrasonographic features of axillary lymph node metastasis in patients with breast cancer. Breast. 2009 Apr;18(2):119-22. doi: 10.1016/j.breast.2009.02.004. Epub 2009 Mar 17.
citation: Huvos AG, Hutter RV, Berg JW. Significance of axillary macrometastases and micrometastases in mammary cancer. Ann Surg. 1971 Jan;173(1):44-6. doi: 10.1097/00000658-197101000-00006. No abstract available.
citation: LEBORGNE R, LEBORGNE F Jr, LEBORGNE JH. SOFT-TISSUE RADIOGRAPHY OF AXILLARY NODES WITH FATTY INFILTRATION. Radiology. 1965 Mar;84:513-5. doi: 10.1148/84.3.513. No abstract available.
citation: Ahuja A, Ying M. An overview of neck node sonography. Invest Radiol. 2002 Jun;37(6):333-42. doi: 10.1097/00004424-200206000-00005.
citation: Chikui T, Yonetsu K, Nakamura T. Multivariate feature analysis of sonographic findings of metastatic cervical lymph nodes: contribution of blood flow features revealed by power Doppler sonography for predicting metastasis. AJNR Am J Neuroradiol. 2000 Mar;21(3):561-7.
citation: Rubaltelli L, Proto E, Salmaso R, Bortoletto P, Candiani F, Cagol P. Sonography of abnormal lymph nodes in vitro: correlation of sonographic and histologic findings. AJR Am J Roentgenol. 1990 Dec;155(6):1241-4. doi: 10.2214/ajr.155.6.2122673.
citation: Woolgar JA, Rogers SN, Lowe D, Brown JS, Vaughan ED. Cervical lymph node metastasis in oral cancer: the importance of even microscopic extracapsular spread. Oral Oncol. 2003 Feb;39(2):130-7. doi: 10.1016/s1368-8375(02)00030-1.
citation: Chudobinski C, Swiderski B, Antoniuk I, Kurek J. Enhancements in Radiological Detection of Metastatic Lymph Nodes Utilizing AI-Assisted Ultrasound Imaging Data and the Lymph Node Reporting and Data System Scale. Cancers (Basel). 2024 Apr 19;16(8):1564. doi: 10.3390/cancers16081564.