TIRADS Classification System
TIRADS (Thyroid Imaging Reporting and Data System) is a standardized ultrasound-based risk stratification system developed by the American College of Radiology to assess malignancy risk in thyroid nodules and guide decisions about fine needle aspiration biopsy. 1
Core Classification Structure
The ACR TIRADS system assigns points based on five ultrasound features to calculate a total score that determines the risk category: 2
- Composition: Solid nodules carry higher malignancy risk than cystic nodules; cystic nodules or those with <10% solid component are typically benign 1
- Echogenicity: Hypoechoic nodules are more suspicious, while isoechoic nodules have intermediate risk 1
- Shape: Taller-than-wide configuration increases suspicion for malignancy 2
- Margin: Smooth, well-defined borders are associated with benign nodules, while irregular or infiltrative margins suggest malignancy 1
- Echogenic foci: Presence of microcalcifications, macrocalcifications, or peripheral calcifications affects risk stratification 2
Risk Categories and Malignancy Rates
The system stratifies nodules into five categories with corresponding malignancy risks: 3, 4
- TR1 (Benign): 0% risk of malignancy
- TR2 (Not suspicious): 0-4.2% risk of malignancy
- TR3 (Mildly suspicious): 2.1-13.3% risk of malignancy
- TR4 (Moderately suspicious): 15.6-57.9% risk of malignancy
- TR5 (Highly suspicious): 68.9-100% risk of malignancy
FNA Biopsy Thresholds
The ACR TIRADS uses size-based thresholds that vary by risk category to determine when FNA is indicated: 1
- TR3 nodules: FNA recommended at ≥1.5 cm
- TR4 nodules: FNA recommended at ≥1.0 cm
- TR5 nodules: FNA recommended at ≥0.5 cm
- TR1 and TR2 nodules: No FNA recommended regardless of size
Research suggests that nodules with TIRADS 4-5 and diameter <12 mm are highly suspicious and should be considered for FNA even below standard thresholds. 5
Diagnostic Performance
The ACR TIRADS demonstrates strong diagnostic accuracy: 3, 6
- Sensitivity: 74.6-91.67% for detecting malignant nodules
- Specificity: 52.8-89.6%
- Positive predictive value: 66.6%
- Negative predictive value: 93.8%
- Inter-observer agreement: Substantial (kappa 0.77) 4
Nodules meeting FNA criteria have 3 times greater chance of malignancy compared to those that do not. 4
Clinical Application Algorithm
Initial assessment should include: 1
- Thyroid function tests (TSH measurement) as the initial laboratory assessment
- High-quality thyroid ultrasound with systematic evaluation of all five features
- Assignment of TIRADS category based on cumulative point score
- Determination of FNA indication based on category and size thresholds
For nodules not meeting FNA criteria: 1
- Ultrasound follow-up in 6-12 months is recommended
- Continued surveillance at 12-24 month intervals for stable nodules
For nodules undergoing FNA: 7
- US-guided FNA is more accurate, economical, and safer than palpation-guided approaches
- Local anesthesia (1-2% lidocaine) should be used
- Continued surveillance at 12-24 month intervals for benign FNA results
Important Limitations and Caveats
The system has several recognized limitations: 1, 8
- False-negative rate of 5-10% for FNA biopsies, requiring maintained clinical suspicion when other concerning features are present
- Cannot distinguish follicular adenoma from follicular carcinoma, which requires histologic assessment of capsular or vascular invasion
- Cytology rarely provides reliable cancer subtype information
Clinical risk factors may warrant more aggressive evaluation regardless of TIRADS score: 8
- History of head and neck irradiation
- Family history of thyroid cancer
- Suspicious physical exam findings (firm, fixed nodule, rapid growth)
- Presence of suspicious cervical lymphadenopathy
The overall rate of thyroid cancer in patients with nodules is less than 3-5%, with generally favorable prognosis, which supports the conservative size thresholds used in the system. 8