Trial Title:
LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes
NCT ID:
NCT06527027
Condition:
Lymph Node Neoplasm
Lymph Node Metastasis
Conditions: Official terms:
Lymphatic Metastasis
Conditions: Keywords:
Lymph Nodes
Lymph Node Excision
Tomography, X-ray computed
Lymphadenopathy
Recurrence
Magnetic Resonance Imaging
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Lymph node assessment according to RECIST 1.1 in CT
Description:
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.
Arm group label:
Lymph node assessment according to RECIST 1.1
Intervention type:
Other
Intervention name:
Lymph node assessment according to Node-RADS in CT
Description:
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.
Arm group label:
Lymph node assessment according to Node-RADS
Intervention type:
Other
Intervention name:
Lymph node assessment according to LN-RADS in CT
Description:
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
Arm group label:
Lymph node assessment according to LN-RADS
Intervention type:
Other
Intervention name:
Lymph node assessment according to RECIST 1.1 in MRI
Description:
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.
Arm group label:
Lymph node assessment according to RECIST 1.1
Intervention type:
Other
Intervention name:
Lymph node assessment according to Node-RADS in MRI
Description:
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.
Arm group label:
Lymph node assessment according to Node-RADS
Intervention type:
Other
Intervention name:
Lymph node assessment according to LN-RADS in MRI
Description:
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
Arm group label:
Lymph node assessment according to LN-RADS
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Copernicus Memorial Hospital
Address:
City:
Łódź
Zip:
93-513
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Cezary Chudobiński, PhD
Phone:
+4842 689 58 99
Email:
cezary.chudobinski@wp.pl
Investigator:
Last name:
Cezary Chudobiński, PhD
Email:
Principal Investigator
Start date:
December 1, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Copernicus Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Medical Research Agency, Poland
Agency class:
Other
Source:
Copernicus Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06527027
https://lnrads.com
