Breast Imaging Reporting & Data System · ACR 5th Edition

BI-RADS Classification

Malignancy Risk Assessment · Mammography · Ultrasound · MRI
Categories
0 – 2
Benign / Incomplete
Risk: 0% (defined benign)
Category
3
Probably Benign
Risk: < 2% malignancy
Category
4A–C
Suspicious
Risk: 2% – 95%
Categories
5 – 6
Malignant
Risk: ≥ 95% / Known
Category Classification & Malignancy Risk BI-RADS 0 through 6 · Applies to Mammography, Ultrasound & MRI · Subcategories 4A, 4B, 4C
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Category Assessment Malignancy Risk Clinical Interpretation Recommended Action
0
IncompleteNEEDS EVALUATION
Requires additional imaging evaluation and/or prior mammograms for comparison; assessment cannot be completed from current images alone Additional Imaging
1
NegativeNO ABNORMALITY
0%
No abnormality detected; breasts are symmetric; no masses, architectural distortion or suspicious calcifications identified on imaging Routine Screening
2
BenignDEFINITELY BENIGN
0%
Benign findings recorded for reference; includes simple cysts, intramammary lymph nodes, stable fat-containing lesions, fibroadenomas with calcifications Routine Screening
3
Probably BenignSHORT-TERM FOLLOW-UP
< 2%
Finding has high probability of being benign; not expected to change, but short-term follow-up is prudent to confirm stability; biopsy if stability not confirmed at 2–3 years 6-Month Follow-Up
◆ Category 4 — Suspicious (Subdivided 4A · 4B · 4C) · Tissue sampling recommended for all
4A
Low SuspicionBIOPSY RECOMMENDED
2 – 10%
Low suspicion for malignancy; requires tissue sampling; if benign concordant result obtained, 6-month follow-up imaging is acceptable management Tissue Biopsy
4B
Moderate SuspicionBIOPSY REQUIRED
10 – 50%
Moderate suspicion; tissue sampling required; close radiologic-pathologic correlation is essential; discordant benign result requires repeat biopsy or surgical excision Biopsy + Correlation
4C
High SuspicionSTRONGLY SUSPICIOUS
50 – 95%
High suspicion; malignant pathology result expected; discordant benign histology should prompt immediate repeat biopsy or surgical referral without delay Urgent Biopsy
5
Highly SuggestiveOF MALIGNANCY
≥ 95%
Highly suggestive of malignancy; appropriate action should be taken; biopsy required; neoadjuvant systemic therapy may be initiated prior to definitive surgical management Biopsy + Treatment
6
Known MalignancyBIOPSY-PROVEN
N/A
Biopsy-proven malignancy prior to definitive therapy; imaging used to assess extent of disease, treatment response to neoadjuvant chemotherapy, or pre-surgical planning Surgical / Oncology
Imaging Modalities & Lexicon Application BI-RADS lexicon applied across all three breast imaging modalities with modality-specific descriptors
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Modality Primary Use Key Descriptors Modality-Specific Notes
Mammography2D / 3D TOMO Primary screening modality; annual screening from age 40–50 (guideline-dependent); diagnostic mammography for symptomatic patients Masses · Calcifications Describes masses (shape, margin, density), calcifications (morphology, distribution), architectural distortion, asymmetries. Tomosynthesis (3D) reduces recall rates and improves cancer detection vs 2D alone.
UltrasoundTARGETED / WHOLE BREAST Problem-solving for mammographic findings; first-line in patients <30 years or pregnant; characterises palpable lumps; guides biopsy procedures Shape · Margin · Echo Assesses mass shape (oval/round/irregular), orientation, margin (circumscribed/spiculated), echo pattern (anechoic/hypoechoic), posterior acoustic features. Elastography adjunct for stiffness characterisation.
Breast MRICONTRAST-ENHANCED High-risk screening (BRCA carriers); pre-surgical staging; evaluate treatment response; occult primary breast cancer; implant integrity assessment Kinetics · Enhancement Evaluates focus, mass, non-mass enhancement (NME); kinetic curve analysis (initial rise + delayed phase); background parenchymal enhancement (BPE); highest sensitivity (~95%) but lower specificity than mammography.
Clinical Management Pathway Action steps, follow-up intervals, and biopsy decision criteria per BI-RADS category
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Category Immediate Action Follow-Up Interval Pathway Detail & Rationale
0
Recall / Add Views Immediate / ASAP Obtain additional imaging: spot compression, magnification views, ultrasound correlation, or comparison with prior studies. Do not issue a management recommendation until assessment is complete.
1
Routine Screening Annual (age-appropriate) Continue age-appropriate routine mammographic screening. No additional workup required. Negative report should explicitly state no abnormality to reduce patient anxiety.
2
Routine Screening Annual (age-appropriate) Benign finding documented for radiological record. No biopsy or additional imaging required. Examples: simple cysts, oil cysts, milk of calcium, fibroadenoma with coarse calcifications.
3
Short-Interval Imaging 6 months → 12 → 24 months Initial 6-month follow-up of affected breast, then bilateral imaging at 12 and 24 months. If stable over 2–3 years → upgrade to BI-RADS 2. If increased in size or changed morphology → upgrade to BI-RADS 4 and biopsy.
4A
Tissue Sampling Post-biopsy 6-month follow-up Core needle biopsy (CNB) or vacuum-assisted biopsy (VAB). If result is benign and concordant with imaging → 6-month short-interval follow-up acceptable. Discordant result → repeat sampling.
4B
Biopsy + Correlation Pathology review within 5 days CNB mandatory; close radiologic-pathologic correlation required. Benign concordant result may be followed; discordant or high-risk histology (ADH, ALH) requires surgical excision or MDT discussion.
4C
Urgent Biopsy Urgent pathology review CNB with clip marker placement; urgent pathology review. Any benign result that is discordant with high-suspicion imaging requires immediate repeat biopsy or surgical excision — do not accept discordant benign results.
5
Biopsy + Oncology MDT referral within 2 weeks CNB with marker clip; refer to breast MDT. Neoadjuvant chemotherapy may be initiated after biopsy confirmation to downstage disease before surgery. Staging CT/PET may be indicated.
6
Active Treatment Interim response imaging Imaging used to assess extent of disease, tumour response to neoadjuvant chemotherapy (mid-treatment and pre-surgical), and surgical planning (BCS vs mastectomy). MRI preferred for treatment response assessment.
Clinical Pearls, Pitfalls & Special Populations Key considerations for accurate BI-RADS assignment and safe patient management
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Type Topic Detail
Pearl Dense Breast Tissue Heterogeneously or extremely dense breasts (ACR C/D) reduce mammographic sensitivity to ~40–60%. Supplemental ultrasound or MRI screening should be discussed. Dense tissue is an independent risk factor for breast cancer.
Pearl High-Risk Screening Patients with ≥20% lifetime risk (BRCA1/2, TP53, strong family history) should receive annual breast MRI in addition to mammography from age 25–30. MRI sensitivity ~95% vs mammography ~40% in BRCA carriers.
Caution BI-RADS 3 in Diagnostic Setting BI-RADS 3 should not be assigned in a diagnostic (symptomatic) setting or after incomplete workup. It is only appropriate when additional views and ultrasound correlation have been performed and the probability of malignancy is demonstrably <2%.
Caution Pregnancy & Lactation Ultrasound is first-line in pregnant/lactating women. Mammography is safe during pregnancy (low radiation dose). MRI without gadolinium acceptable; gadolinium contrast avoided in first trimester; used cautiously thereafter.
Pitfall Discordant Pathology Radiologic-pathologic discordance is the most critical pitfall: a benign biopsy result for a BI-RADS 4C or 5 lesion must NOT be accepted. False negative CNB rates of 1–3% exist; discordance mandates repeat sampling or surgical excision.
Pitfall Bilateral Synchronous Lesions Assign individual BI-RADS category to each lesion and each breast. The overall assessment should reflect the most actionable (highest) category finding. Do not average or combine findings from different breasts.
Limitation Male Breast Disease BI-RADS lexicon is validated primarily in females. Application in male breast is extrapolated. Gynaecomastia can be BI-RADS 2 if classic subareolar pattern. Eccentric, hard or ulcerated lesions should be promptly biopsied regardless of imaging appearance.
Limitation Implants Standard 2-view mammography is supplemented by implant-displaced (Eklund) views. Breast tissue posterior to implant may be incompletely visualised. Ultrasound and MRI are adjuncts for implant integrity and parenchymal evaluation.