Lung-RADS
Lung-RADS (or lung imaging reporting and data system) is a classification proposed to aid with findings in low-dose CT screening exams for lung cancer. The goal of the classification system is to standardize follow-up and management decisions. The system is similar to the Fleischner criteria but designed for the subset of patients intended for low-dose screening studies.
Classification system
Category 0 (incomplete)
- prior CT studies were performed, but are not available for comparison
- lungs are incompletely imaged
Category 1 (negative, <1% chance of malignancy)
- no lung nodules
- lung nodule(s) with specific findings favoring benign nodule(s)
- complete calcification
- central calcification
- popcorn calcification
- calcification in concentric rings
- fat-containing nodules
Category 2 (benign appearance, <1% chance of malignancy)
- solid nodule(s)
- <6 mm at baseline
- new nodule <4 mm
- subsolid nodule(s)
- <6 mm on baseline screening
- ground glass nodule(s)
- <30 mm (Version 1.1 change previously 20 mm)
- ≥30 mm and unchanged or slowly growing (Version 1.1 change previously 20 mm)
- category 3 or 4 nodules that are unchanged for ≥3 months
Category 3 (probably benign, 1-2% chance of malignancy)
- solid nodule(s)
- ≥6 mm to <8 mm at baseline
- new nodule 4 mm to <6 mm
- subsolid nodule(s)
- ≥6 mm total diameter with solid component <6 mm
- new <6 mm total diameter
- ground glass nodule(s)
- ≥30 mm on baseline CT or new (Version 1.1 change previously 20 mm)
Category 4A ( Probably suspicious, 5-15% chance of malignancy) (Version 1.1 change previously suspicious)
- solid nodule(s)
- ≥8 mm to <15 mm at baseline
- growing nodule(s) <8 mm
- new nodule 6 mm to <8 mm
- subsolid nodule(s)
- ≥6 mm total diameter with solid component ≥6 mm to <8 mm
- new or growing <4 mm solid component
- endobronchial nodule
Category 4B (suspicious, >15% chance of malignancy)
- solid nodule(s)
- ≥ 15 mm at baseline
- new or growing, and ≥8 mm
- subsolid nodule(s)
- solid component ≥8 mm
- new or growing ≥4 mm solid component
- For new large nodules that develop on an annual repeat screening CT, a 1 month LDCT may be recommended to address potentially infectious or inflammatory conditions. (Version 1.1 addition)
Category 4X (suspicious, >15% chance of malignancy)
- category 3 or 4 nodules with additional features or imaging findings that increase the suspicion of malignancy
- includes:
- spiculation
- ground glass nodule(s) that double in size in 1 year
- enlarged regional lymph nodes
- For new large nodules that develop on an annual repeat screening CT, a 1 month LDCT may be recommended to address potentially infectious or inflammatory conditions. (Version 1.1 addition)
Modified categories
- [X]S (e.g. "3S") if there is a clinically significant or potentially significant non-lung cancer finding
- (Version 1.1 REMOVAL): [X]C (e.g. "3C") for a patient with a prior diagnosis of lung cancer who returns to screening
Recommended follow-up
Category 0:
- comparison with prior studies before assignment of Lung-RADS classification
Category 1:
- continue annual screening with LDCT
Category 2:
- continue annual screening with LDCT
Category 3:
- 6-month follow-up with LDCT
Category 4A:
- 3-month follow-up with LDCT
- PET/CT may be used if there is a ≥8 mm solid component
Category 4B and 4X:
- chest CT with or without contrast, as appropriate
- PET-CT and/or tissue sampling depending on the probability of malignancy and comorbidities (PET-CT if solid component ≥8 mm)
- For new large nodules that develop on an annual repeat screening CT, a 1 month LDCT may be recommended to address potentially infectious or inflammatory conditions. (Version 1.1 addition)
Practical points
- nodule measurement should be in lung windows
- To calculate nodule mean diameter, measure both the long and short axis to one decimal point, and report mean nodule diameter to one decimal point. [previously recommended rounding to nearest whole number version 1.0.]
- only a single measurement is necessary for round nodules
- "growth" is an increase in size of ≥1.5 mm
- assignment of a Lung-RADS status is based on the most suspicious nodule
- category 4B management is based on multiple factors including overall patient status and patient preference
- Solid nodules with smooth margins, an oval, lentiform or triangular shape, and maximum diameter less than 10 mm (perifissural nodules) should be classified as category 2. (Version 1.1 addition)