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

NARecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Lymph Node NeoplasmLymph Node Metastasis
Interventions
OTHER

Lymph node assessment according to RECIST 1.1 in CT

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.

OTHER

Lymph node assessment according to Node-RADS in CT

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.

OTHER

Lymph node assessment according to LN-RADS in CT

"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"

OTHER

Lymph node assessment according to RECIST 1.1 in MRI

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.

OTHER

Lymph node assessment according to Node-RADS in MRI

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.

OTHER

Lymph node assessment according to LN-RADS in MRI

"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"

Trial Locations (1)

93-513

RECRUITING

Copernicus Memorial Hospital, Lodz

Sponsors
All Listed Sponsors
collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

Copernicus Memorial Hospital

OTHER

NCT06527027 - LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes | Biotech Hunter | Biotech Hunter