Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527027
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
LN-RADS RECIST 11 and Node-RADS Classification in the Assessment of Lymph Nodes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the LN-RADS RECIST 11 and Node-RADS Classification in the Assessment of Lymph Nodes in MRI and CT in Relation to Histopathological Results - a Prospective Randomised Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 and Node-RADS
The main tested system in the study is LN-RADS the comparators are RECIST 11 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 11 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 11 method This means that currently according to RECIST 11 rules approx 20 of patients have missed nodal metastases and consequently receive insufficient treatment resulting in relapse Previous studies have shown that RECIST 11 shows a high level of underestimation of metastatic nodes The Node-RADS system as the second comparator next to RECIT 11 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
The main tested system in the study is LN-RADS the comparators are RECIST 11 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 11 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 11 method This means that currently according to RECIST 11 rules approx 20 of patients have missed nodal metastases and consequently receive insufficient treatment resulting in relapse Previous studies have shown that RECIST 11 shows a high level of underestimation of metastatic nodes The Node-RADS system as the second comparator next to RECIT 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None