Lymph Node NeoplasmNCT06527027
LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes
A study testing Lymph node assessment according to RECIST 1.1 in CT, Lymph node assessment according to Node-RADS in CT and Lymph node assessment according to LN-RADS in CT in people with Lymph Node Neoplasm and Lymph Node Metastasis, run by Copernicus Memorial Hospital at 6 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Neoplasm, Lymph Node Metastasis
- What is being tested?
- Lymph node assessment according to RECIST 1.1 in CT, Lymph node assessment according to Node-RADS in CT and Lymph node assessment according to LN-RADS in CT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 6 sitesPoland
- Study dates
- 1 Dec 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Poland6 sites, 1 recruiting
- Active, not recruiting
Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute
Krakow
- Recruiting
Copernicus Memorial Hospital
Lodz, 93-513
Cezary Chudobiński, PhD, +4842 689 58 99, cezary.chudobinski@wp.pl
Cezary Chudobiński, PhD
- Active, not recruiting
Independent Public Healthcare Centre (SPZOZ) , University Clinical Hospital No. 2 of the Medical University of Łódź
Lodz
- Active, not recruiting
Doradztwo i Zarządzanie w Opiece Zdrowotnej A.K. Sp.z o.o
Warsaw
- Active, not recruiting
Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute
Warsaw
- Active, not recruiting
Professor Orłowski Hospital in Warsaw , Independent Public Healthcare Centre
Warsaw
About this study
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
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.
Read more
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.
- Conditions
- Lymph Node Neoplasm, Lymph Node Metastasis
- Being tested
- 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
- Keywords
- Lymph Nodes, Lymph Node Excision, Tomography, X-ray computed, Lymphadenopathy, Recurrence, Magnetic Resonance Imaging
- Medical subject headings
- Lymphatic Metastasis, Lymphadenopathy, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph node assessment according to RECIST 1.1 in CTOther
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 CTOther
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 CTOther
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 MRIOther
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 MRIOther
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 MRIOther
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
| Study group | Role | What they receive |
|---|---|---|
| Lymph node assessment according to RECIST 1.1 | Sham comparator | Not described Receives: Other: Lymph node assessment according to RECIST 1.1 in CT; Other: Lymph node assessment according to RECIST 1.1 in MRI |
| Lymph node assessment according to LN-RADS | Experimental | Not described Receives: Other: Lymph node assessment according to LN-RADS in CT; Other: Lymph node assessment according to LN-RADS in MRI |
| Lymph node assessment according to Node-RADS | Experimental | Not described Receives: Other: Lymph node assessment according to Node-RADS in CT; Other: Lymph node assessment according to Node-RADS in MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After accomplished lymph node assessment according to classification system (up to 1 year)
Secondary outcomes (2)
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.
Measured: 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.
Measured: After accomplished lymph node assessment according to classification system (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lymph Node NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copernicus Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Cezary Chudoniński, Copernicus Memorial Hospital
- Investigators
- Cezary Chudobiński, PhD, Principal investigator, Copernicus Memoriał Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527027
- Sponsor's protocol ID
- 2022/ABM/03/00027
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33585994Prenzel 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.
PubMed 12576367Yoshimura 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.
PubMed 11091725Choi 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.
PubMed 19297159Huvos 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.
PubMed 5543548LEBORGNE 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.
PubMed 14280727Ahuja A, Ying M. An overview of neck node sonography. Invest Radiol. 2002 Jun;37(6):333-42. doi: 10.1097/00004424-200206000-00005.
PubMed 12021590Chikui 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.
PubMed 10730652Rubaltelli 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.
PubMed 2122673Woolgar 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.
PubMed 12509965Chudobinski 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.
PubMed 38672646
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06527027
- Acronym / sponsor ID
- 2022/ABM/03/00027
- Conditions
- Lymph Node Neoplasm, Lymph Node Metastasis
- Keywords
- Lymph Nodes, Lymph Node Excision, Tomography, X-ray computed, Lymphadenopathy, Recurrence, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copernicus Memorial HospitalUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lymph node assessment according to RECIST 1.1 | Sham comparator | Other: Lymph node assessment according to RECIST 1.1 in CT, Other: Lymph node assessment according to RECIST 1.1 in MRI |
| Lymph node assessment according to LN-RADS | Experimental | Other: Lymph node assessment according to LN-RADS in CT, Other: Lymph node assessment according to LN-RADS in MRI |
| Lymph node assessment according to Node-RADS | Experimental | Other: Lymph node assessment according to Node-RADS in CT, Other: Lymph node assessment according to Node-RADS in MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymph node assessment according to RECIST 1.1 in CTRECIST 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 |
| Lymph node assessment according to Node-RADS in CTNode-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 |
| Lymph node assessment according to LN-RADS in CTLN-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 |
| Lymph node assessment according to RECIST 1.1 in MRIRECIST 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 |
| Lymph node assessment according to Node-RADS in MRINode-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 |
| Lymph node assessment according to LN-RADS in MRILN-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 |
Primary outcome
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).
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 33585994Elsholtz 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.
- Background: PubMed 12576367Prenzel 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.
- Background: PubMed 11091725Yoshimura 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.
- Background: PubMed 19297159Choi 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.
- Background: PubMed 5543548Huvos 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.
- Background: PubMed 14280727LEBORGNE 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.
- Background: PubMed 12021590Ahuja A, Ying M. An overview of neck node sonography. Invest Radiol. 2002 Jun;37(6):333-42. doi: 10.1097/00004424-200206000-00005.
- Background: PubMed 10730652Chikui 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.
- Background: PubMed 2122673Rubaltelli 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.
- Background: PubMed 12509965Woolgar 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.
- Results publication: PubMed 38672646Chudobinski 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cezary Chudobiński, PhD principal investigator
Copernicus Memoriał Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymph node assessment according to RECIST 1.1 in CT, Lymph node assessment according to Node-RADS in CT and Lymph node assessment according to LN-RADS in CT in people with Lymph Node Neoplasm and Lymph Node Metastasis, run by Copernicus Memorial Hospital at 6 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cezary Chudobiński, PhD (+4842 689 58 99, cezary.chudobinski@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527027, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.