BI-RADS 3 lesions in North Indian population: Their outcome and how to proceed for follow-up

Abstract

Background: 

Breast Imaging Reporting and Data System (BI-RADS) classification for breast lesions was proposed for uniformity in categorizing breast lesions. While BI-RADS 1, 2 and 4–6 categories are straightforward, BI-RADS 3 is an intermediate category lesion with significantly different meanings and findings for mammography, ultrasound, and magnetic resonance imaging and is diagnostically challenging. Our study aims to determine the frequency and the malignancy rate of BI-RADS category 3 lesions detected on ultrasound breast and digital X-ray mammography by doing follow-ups at 6, 12, and 24 months of imaging.

Materials and Methods: 

This ambispective study was conducted in the Department of Radiodiagnosis, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, from October 2020 to October 2022, which included 55 patients referred for digital X-ray and breast ultrasound. All BI-RADS category 3 in the initial sonomammography and digital X-ray mammography were included in the study and were followed up for final diagnosis and outcome either by pathological analysis or follow-up using sonomammography and digital X-ray mammography for a maximum of 24 months.

Results: 

Fifty-five patients were categorized into the benign or malignant category from the results of tissue diagnosis or via follow-up. Fifty-four patients (98.18%) showed benign lesions, and one (1.82%) got malignant lesions. In the majority, 31 (56.36%) patients, the mean follow-up time was 6 months, followed by 12 months 10 (18.18%). Follow-up was 24 months in only 1 out of 55 patients (1.82%). The mean value of time to follow-up (months) of study subjects was 6 ± 4.6 with a median (25th–75th percentile) of 6.

Conclusion: 

Short-term interval follow-up in BI-RADS category: three patients are enough to detect early breast malignancy, and this will avoid unnecessary tissue diagnosis (invasive procedure) in benign lesions. In our study, the malignancy yield in the follow-up of BI-RADS 3 was 1.82% (<2%).

INTRODUCTION

Breast Imaging Reporting and Data System (BI-RADS) lexicon is a group of descriptive terms used to describe mammographic, ultrasound, or magnetic resonance imaging findings. Hence, better report organization and communication are possible between the radiologist and referring physicians by giving a final assessment and management recommendations.^[1]

BI-RADS 1 is normal, with no abnormalities at all. BI-RADS 2 is a purely benign lesion, and BI-RADS 4 is a suspicious malignant lesion. BI-RADS 5 is a highly suspicious lesion for malignancy, and BI-RADS 6 is a biopsy-proven case of carcinoma. These are relatively straightforward with not much confusion. Probably benign (BI-RADS 3) is an intermediate category lesion with significantly different meanings and findings for mammography, ultrasound, and magnetic resonance imaging.

BI-RADS category 3 lesions are probably benign, and short-interval follow-up is the recommendation. They have a 2% or lower likelihood of cancer, according to the American College of BI-RADS lexicon.^[2]

Reduction of false-positive findings with retaining a high sensitivity for picking up early-stage breast cancer and preventing many patients from an unnecessary biopsy of benign lesions are the benefits of short-term follow-up. As BI-RADS category 3 lesions are diagnostically challenging, they should be carefully followed up. A complete assessment is advised at the initial diagnosis of BI-RADS 3, which will avoid unnecessary biopsies. Avoiding early microscopic tissue correlation can decrease harm to the patient and reduce the screening cost.^[3-5]

However, if there are sonographic morphological changes or mammographic features that are suspicious of malignancy, the lesion is upgraded to BI-RADS 4, and a biopsy is indicated.^[6]

Six months, 12 months, and 24 months are the recommended surveillance protocol for ensuring stability and continued benign appearance of the lesion done with either X-ray or ultrasound mammography.^[7]

Our study aims to determine the frequency and the malignancy rate of BI-RADS category 3 lesions detected on ultrasound breast and digital X-ray mammography by doing follow-up of BI-RADS category 3 lesions on ultrasound breast/X-ray mammography imaging with final clinical diagnosis and outcome by histopathological diagnosis and 6, 12, and 24 months imaging follow-up as per protocol.

MATERIALS AND METHODS

The study was conducted in the Department of Radiodiagnosis from October 2020 to October 2022, which included 55 female patients referred to the Department of Radiodiagnosis for Digital X-ray and ultrasound breast. Patients who presented for follow-up (October 2020 to October 2022) were included if their first mammogram showed a BI-RADS category 3 lesion (per ACR guidelines). Other category lesions, postsurgical or postintervention cases, were excluded. The study was begun after obtaining valid written consent from the patient and institutional ethical committee clearance. All BI-RADS category 3 in the initial sonomammography and digital X-ray mammography were included in the study and were followed up for final diagnosis and outcome either by pathological analysis or follow-up using ultrasound breast and digital X-ray mammography for a maximum of 24 months as per protocol.

For digital mammography, Siemens Mammomat 3000 Nova Elema AB digital mammography machine was used by taking two standard image planers, the mediolateral oblique and craniocaudal views, standing with proper positioning. For the ultrasound of breast, Toshiba Aplioistyle XG/Siemens Acuson 700 with high-frequency (7–12 MHz) and low-frequency (3–5 MHz) transducers, mainly the high-frequency probe was used with the harmonic resolution, and patients were examined in supine position with proper positioning. Both breasts were exposed adequately, along with the axilla. Radial and antiradial sweeping of the transducer was done to look for any abnormality. A senior radiologist made image interpretation with over 12 years of experience in women’s imaging.

Follow-up was done with an ultrasound breast at 6 months, 12 months, and 24 months, and the BI-RADS category was upgraded, downgraded, or remained static at each follow-up. If there was no significant change in the size or characteristics of the lesion, the follow-up was continued for 24 months, as per protocol. After that, routine follow-up was advised, and the lesion was categorized as BI-RADS 2 at the end of 24 months.

Histopathology reports were considered for an outcome either with FNAC or biopsy reports, which clearly labeled a lesion as benign or malignant. Data were collected and entered into a Microsoft Excel spreadsheet and were analyzed statistically and interpreted. The final analysis used Statistical Package for Social Sciences (SPSS ver. 25.0) software, IBM Manufacturer, Chicago, USA.

OBSERVATION AND RESULTS

Characteristics of breast lesions on ultrasound breast at the first scan

All 55 patients have undergone ultrasound breast, of which the majority (49 [89.09%]) of the breast composition was homogenous fibroglandular, and the rest of the six patients had heterogeneous breast composition. The majority of the lesions were oval (98.18%), with circumscribed margins (72.73%), along with macrolobulations in 27.27%; all had parallel orientation, the majority were hypoechoic and lateral edge shadowing as posterior features, few of the lesions showed peripheral echogenic rim of calcification (5.45%) and few patients showed duct ectasia (9.09%) and rounded lymph nodes (1.82%) as associated features. It is shown in Table 1.

Table 1: - Characteristics of breast lesions on sonomammography at the first scan

Sonomammography findings	Frequency	Percentage
Breast composition
Homogenous—fibroglandular	49	89.09
Heterogenous	6	10.91
Shape
Oval	54	98.18
Round	1	1.82
Margin
Circumscribed	40	72.73
Circumscribed with macrolobulation	15	27.27
Orientation
Parallel	55	100.00
Not parallel	0	0
Echo pattern
Complex cystic lesion	1	1.82
Heterogeneous predominantly hypoechoic	1	1.82
Hyperechoic	1	1.82
Hyperechoic with few cystic areas	1	1.82
Hypoechoic	46	83.64
Hypoechoic with few cystic areas	5	9.09
Posterior features
Nil	2	3.64
Lateral edge shadowing	53	96.36
Calcification
Nil	52	94.55
The peripheral echogenic rim of calcification	3	5.45
Associated features
Nil	49	89.09
Duct ectasia	5	9.09
Round lymph nodes on left axilla	1	1.82

Characteristics of breast lesions on X-ray mammography at the first scan

Only 24 patients underwent digital mammography, of which 14 patients (58.33%) patients had heterogeneously dense (type C) breasts and the rest of the patients had type B (scattered areas of fibroglandular density) breasts. The lesions appeared oval, circumscribed, few with microlobulation, and high density. A few of the lesions (8.33%) showed macrocalcification within them. However, 6 out of 24 patients failed to demonstrate lesions in digital mammography, which was obvious in ultrasound breast. These patients had type C breasts where heterogeneously dense breasts obscured small lesions. However, none of the patients showed any asymmetry, architectural distortion, or associated features. This is shown in Table 2.

Table 2: - Characteristics of breast lesions on X-ray mammography at the first scan

Digital mammography findings at the first scan (n = 24)	Frequency	Percentage
Breast composition
Heterogeneously dense (type C)	14	58.33
Scattered areas of fibroglandular density (type B)	10	41.67
Shape
Mass not visible	6	25.00
Oval	18	75.00
Margin
Mass not visible	6	25.00
Circumscribed	10	41.67
Circumscribed with macrolobulation	8	33.33
Lesion density
Mass not visible	6	25.00
High dense	18	75.00
Calcification
None	22	91.67
Macrocalcification	2	8.33

Distribution of biopsy/FNAC findings of study subjects

Of 55 patients, 46 (83.63%) have undergone tissue diagnosis. That one lesion turned out to be malignant (2.17%), which showed ducal carcinoma in situ in histopathology; the rest of the lesions turned out to be benign (97.8%). Fibroadenoma was the most common benign lesion, followed by benign proliferative breast disease, then tubercular mastitis. Other benign lesions were phyllodes tumors, proliferative breast disease with mild atypia, and granulomatous mastitis, as shown in Table 3.

Table 3: - Distribution of biopsy/FNAC findings of study subjects

Biopsy/FNAC finding	Frequency	Percentage
Not done	9	16.36
Benign epithelial cells	2	3.64
Benign proliferative breast disease	4	7.27
Ductal carcinoma in situ	1	1.82
Fibroadenoma	34	61.82
Granulomatous mastitis	1	1.82
Phyllodes tumor	1	1.82
Proliferative breast disease with mild atypia	1	1.82
Tubercular mastitis	2	3.64
Total	55	100.00

Distribution of outcome at 6-month follow-up of study subjects

Fifty-three out of a total of 55 patients underwent 6-month follow-ups. Most lesions (54.54%) showed a <20% increase in size. A decrease in size was observed in five patients; decrease in size with skin thickening was seen in one patient. One of the lesions showed a <20% increase in size with an indistinct irregular margin. Less than 20% increase in size with a new lesion in the breast was seen in five patients (9.09%), and two new lesions in each breast with no change in the original lesion were seen in one patient. Two patients did not undergo 6-month follow-up since they had undergone tissue diagnosis and were found to be benign. This is shown in Table 4.

Table 4: - Distribution of outcome at 6-month follow-up of study subjects

Result at 6-month follow-up	Frequency	Percentage
The change observed at 6 months
Not done (HPE proven to be benign)	2	3.64
Decrease in size	5	9.09
Decrease in size with overlying skin thickening	1	1.82
No change	10	18.18
<20% size increase	30	54.54
<20% increase in size indistinct irregular margin	1	1.82
<20% size increase with a new lesion in the breast	5	9.09
Two new lesions each in both breasts with no change in the original lesion	1	1.82

BI-RADS categorization at 6-month follow-up showed 46 patients (86.79%) patients in BI-RADS category 3, 6 patients (11.32%) in BI-RADS category 2, and 1 patient (1.88%) in BI-RADS category 4. It is shown in Table 5.

Table 5: - Categorization of lesions at the end of 6-month follow-up

Sonography BI-RADS those who underwent 6-month follow-up (n = 53)	Frequency	Percentage
BI-RADS 2	6	11.32
BI-RADS 3	46	86.79
BI-RADS 4	1	1.88

Distribution of outcome at 12-month follow-up of study subjects

Only 46 patients were subjected to 12 months of follow-up. The rest of the patients either had established histopathological diagnoses or were downgraded as BI-RADS category 2 in the previous follow-up. Most patients (26 patients, 50.91%) showed no change. Three patients showed a decrease in size, 16 patients showed a 20% increase in length, and 1 patient showed a <20% increase in size with a new lesion in the breast. This is shown in Table 6.

Table 6: - Distribution of outcome at 12-month follow-up of study

Outcome at 12-month follow-up	Frequency	Percentage
The change observed at 12 months
Not done (histopathological diagnosis established or downgraded as BI-RADS 2 in the previous follow-up)	9	10.91
No change	26	50.91
Decrease in size	3	5.45
<20% size increase	16	30.91
<20% size increase with a new lesion in the breast	1	1.82

BI-RADS categorization at 12-month follow-up showed that most patients (43 patients), 93.4% remained in category 3, and 3 patients (6.9%) were downgraded to BI-RADS 2. This is shown in Table 7.

Table 7: - Categorization of lesions at the end of 12-month follow-up

Sonography BI-RADS who underwent 12-month follow-up (n = 46)	Frequency	Percentage
BI-RADS 2	3	6.9
BI-RADS 3	43	93.4

Distribution of outcome at 24-month follow-up of study subjects

Forty-one patients were subjected to 24 months of follow-up. The rest of the patients either had established histopathological diagnoses or were downgraded as BI-RADS category 2 in the previous follow-up. Those who have undergone follow-up showed no change in the majority of the patients (61.81%); one patient showed a decrease in size, one patient showed a decrease in size with macrocalcification, five patients (9.09%) showed <20% increase in size. This is shown in Table 8. BI-RADS categorization at 24-month follow-up showed BI-RADS category 2 in 85.36% (35 patients) and BI-RADS category 3 in 14.63%. This is shown in Table 9.

Table 8: - Distribution of outcome at 24-month follow-up of study

Outcome at 24-month follow-up	Frequency	Percentage
Not done (histopathological diagnosis established or downgraded as BI-RADS 2 in the previous follow-up)	14	25.45
Decrease in size	1	1.82
Decrease in size with macrocalcification in lesion	1	1.82
No change	34	61.81
<20% size increase	5	9.09

Table 9: - Categorization of lesions at the end of 24-month follow-up

Sonography BI-RADS who underwent 24-month follow-up (n = 41)	Frequency	Percentage
BI-RADS 2	35	85.36
BI-RADS 3	6	14.63

Distribution of benign/malignant among study subjects

Finally, 55 patients were categorized into benign or malignant from the results of tissue diagnosis or via follow-up. Fifty-four patients (98.18%) showed benign lesions, and 1 (1.82%) had malignant lesions. It is shown in Table 10 and Figure 1.

Table 10: - Distribution of benign/malignant breast lesions among study subjects

Benign/Malignant	Frequency	Percentage
Benign	54	98.18
Malignant	1	1.82
Total	55	100.00

Figure 1:: Distribution of benign and malignant lesions

Distribution of mean time to follow-up (months) of study subjects

In the majority, 31 (56.36%) patients, the mean follow-up time was 6 months, followed by 12 months 10 (18.18%). Follow-up was 24 months in only 1 out of 55 patients (1.82%). The mean value of time to follow-up (months) of study subjects was 6 ± 4.6 with a median (25th–75th percentile) of 6 (6–6). It is shown in Table 11 and Figure 2.

Table 11: - Distribution of mean time to follow-up (months) of study subjects

Mean time to follow-up (months)	Frequency	Percentage
6	31	56.36
12	10	18.18
24	1	1.82
Mean ± SD	6 ± 4.6
Median (25th–75th percentile)	6 (6–6)
Range	0–24

Figure 2:: Distribution of mean time to follow-up (months) of study subjects

Images of representative cases from our study

X-ray mammography showed scattered areas of fibroglandular tissue in both breasts (type b) with an oval circumscribed high-dense lesion noted in the center of the left breast. However, no evidence of any calcification, speculation, or architectural distortion was noted [Figure 3A and B]. Ultrasonography (USG) in a fibroglandular breast showed a well-defined, oval-shaped, circumscribed, predominantly hypoechoic lesion with parallel orientation and lateral edge shadowing (~1.4 × 1.0 cm²) at the 6 o’clock position of the left breast (BI-RADS 3) [Figure 3C]. Low-power view in microscope showed fibroadenoma [Figure 3D]. After 24-month follow-up, the lesion attained stability and was downgraded to BI-RADS 2. Histopathological correlation was found to be fx-adenoma.

Figure 3:: (A, B) X-ray mammography showing scattered areas of fibroglandular tissue in bilateral breast (type b) with an oval circumscribed high dense lesion noted in the center of left breast; however, no evidence of any calcification, speculation, or architectural distortion noted. (C) USG in a fibroglandular breast, a well-defined, oval-shaped, circumscribed, predominantly hypoechoic lesion having parallel orientation and lateral edge shadowing (size ~1.4 × 1.0 cm²) was seen at 6 o’clock position of the left breast (BI-RADS 3). (d) Low-power view in microscope showing fibroadenoma

X-ray mammography showed type B X-rated areas of fibroglandular tissue of right breast, an oval-shaped, well-circumscribed, macrolobulated, high-density lesion in the upper outer quadrant of the right breast (BI-RADS 3). However, no evidence of any calcification, speculation, or architectural distortion was noted [Figure 4A]. USG showed heterogeneous breast tissue with an oval-shaped, well-circumscribed, macrolobulated, parallel-oriented hypoechoic mass lesion (size ~2.4 × 2.2 cm²) involving the upper outer quadrant of the right breast (BI-RADS 3) [Figure 4B].

Figure 4:: (A) X-ray mammography showed type B (scattered areas of fibroglandular tissue) right breast showed an oval-shaped, well-circumscribed, macrolobulated, high-density lesion at the upper outer quadrant of the right breast (BI-RADS 3). However, no evidence of any calcification, speculation, or architectural distortion was noted. (B) USG showed heterogeneous breast tissue with an oval-shaped, well-circumscribed, macrolobulated, parallel-oriented hypoechoic mass lesion (~2.4 × 2.2 cm²) involving the upper outer quadrant of the right breast (BI-RADS 3). (C) This patient underwent tissue diagnosis, which showed the lesion to be tubercular mastitis. The patient underwent antitubercular treatment, and the lesion was significantly reduced in size on follow-up scans

This patient underwent tissue diagnosis, which showed the lesion to be tubercular mastitis. The patient underwent antitubercular treatment, and the lesion significantly reduced in size on follow-up scans.

USG showed the heterogenous left breast of a patient with a round, well-circumscribed, hypoechoic lesion with parallel orientation (size ~12 × 12 mm²) with no significant posterior features involving the upper outer quadrant of the left breast (BI-RADS 3) [Figure 5A]. The same patient followed up at 6 months showed a mild increase in the lesion size (size ~17 × 14 mm²) with an indistinct irregular margin, hence upgraded as BI-RADS 4. A biopsy was done—biopsy of the lesion in a low-power microscope showed ductal carcinoma in situ [Figure 5C].^[8]

Figure 5:: (A) USG showed the heterogenous left breast of a patient with a round, well-circumscribed, hypoechoic lesions with parallel orientation (size ~12 × 12 mm²) with no significant posterior features involving the upper outer quadrant of the left breast (BI-RADS 3). (B) The same patient followed up at 6 months showed a mild increase in the size of the lesion (size ~17 × 14 mm²) with indistinct irregular margin, hence upgraded as BI-RADS 4 and biopsy was done. (C) Biopsy of the lesion in a low-power microscope showing ductal carcinoma in situ

DISCUSSION

In our study, the majority of the patients of BI-RADS 3 were in the age group of 18–30 years (58.18%) and were young, which explains benign outcomes in most of the patients suggesting short-term follow-up in young women.^[9] One of the lesions, categorized as BI-RADS 4 at 6-month follow-up, proved to be ductal carcinoma in situ on biopsy. This patient belonged to a higher age group (41–50 years). As stated in the study by Eugenio et al.,^[10] breast cancers are most common after menopause, and most are diagnosed over the 50s.

Most of the patients (94.5%) presented with a lump in the breast as the chief complaint for undergoing mammography. All the selected 55 patients underwent diagnostic sonomammography, and only 24 underwent diagnostic digital mammography since most of our patients belonged to the young age group. The selective elderly patient underwent a digital mammogram. This was consistent with the study by Devolli Disha et al.,^[11] which proved that for detecting malignant and benign breast lesions, the sensitivity and specificity of ultrasound are higher than mammography in females with breast complaints, mainly in young women with dense breasts. An X-ray mammogram is more sensitive as age increases and the breast becomes fattier.^[12]

The lesions in the breast were categorized as BI-RADS 3 according to ACR BI-RADS atlas 2013.^[1,2] Almost 100% of the lesions in the ultrasound breast had circumscribed margins and parallel orientation. Most lesions were found to be oval, with circumscribed margins, hypoechoic with lateral edge shadowing as posterior features as USG findings. Only 24 patients out of 55 patients underwent initial diagnostic digital mammography. Type C was the most common category of the breast, which obscured the lesion in six patients who underwent mammography and were given the BI-RADS 0 category in digital mammography, recommending additional sonomagraphic evaluation. In sonomammography, they were diagnosed to have BI-RADS 3 lesions. Chae et al.^[5] stated that the frequency of BI-RADS 3 is higher in a sonogram, even in a patient with a normal mammogram.

All lesions in the mammogram were oval with circumscribed margins and high-density lesions. All 55 patients were followed up to know whether the lesion was becoming malignant and hence the chance of BI-RADS 3 becoming malignancy. Follow-up was done by imaging and tissue diagnosis.

Tissue diagnosis, either by FNAC or biopsy, is definitive whether a lesion is benign or malignant. In our study, 46 patients (83.64%) underwent tissue diagnosis at various stages of the study due to various reasons.

Out of 46 patients who underwent tissue diagnosis, 45 (97.88%) patients had benign etiology, and fibroadenoma was the most common (61.8%). This was consistent with Poojasree et al.: fibroadenoma is most common among all breast lesions. It can be seen in any age group.^[12] One patient (2.17%) out of 46 who underwent histopathology was malignant and showed ductal carcinoma in in situ (DCIS). Berg et al.^[4] found that the rate of DCIS among malignant lesions in BI-RADS 3 follow-up is 32.7% which is quite high.

As discussed in a study by Lee et al.,^[7] even though the lesions attain stability in 6- and 12-month follow-up, they are categorized as BI-RADS 3, and further follow-up is recommended; however, attaining stability at 24-month follow-up can be downgraded as BI-RADS 2 or continue as category BI-RADS 3 with 1-year follow-up imaging recommendation with no need of histopathology. In our study, after attaining stability over 24 months, follow-up was downgraded as BI-RADS 2.

All the patients diagnosed with BI-RADS category 3 were advised for short follow-up intervals as per guidelines. However, among 55 initially diagnosed BI-RADS 3 category patients, only 53 underwent 6 months of follow-up, 46 underwent 12 months, and 41 underwent 24 months of follow-up. Two patients underwent histopathology within 6 months, one was found to have six tubercular mastitis for which an antitubercular drug was given. Another was surgically excised and diagnosed as a phyllodes tumor.

At 6-month follow-up, one lesion (1.82%) was upgraded to BI-RADS 4, which showed a <20% increase in size with margins becoming indistinct and irregular. This patient was advised of biopsy and found to be ductal carcinoma in situ, which signifies the importance of scrutinized short-term follow-up. Most patients (86.79%) at 6-month follow-up remained as in category 3. They were advised of further short-term follow-up, and 11.32% of the patients were downgraded as BI-RADS 2 in 6 months, assuming stability of the lesion, thus refraining from further follow-up.

Further 12 months of follow-up has been undertaken by only 46 patients; the rest of the 9 patients’ diagnosis was either histopathologically established or was downgraded as BI-RADS 2 in the previous follow-up. At 12-month follow-up, most patients (93.4%) remained in category BI-RADS 3, and 6.9% were downgraded to BI-RADS 2. However, none of them were upgraded. Only 41 patients underwent 24 months of follow-up from the 46 patients with 12 months of surveillance; the rest had their established diagnosis and were not recommended for follow-up. At 24 months, 85.3% of the patients were downgraded as BI-RADS 2, assuming stability of the lesion, and were further advised for routine follow-up.

This was highly consistent with the documentation done by Berg et al.,^[4] where 83.2% of patients in 24 months of follow-up were downgraded as BI-RADS 1 or 2. About 14.6% of the patients remained in category 3 only. However, they underwent tissue diagnosis and proved benign lesions only. Fifty-four patients (98.18%) in our study were categorized as patients having benign lesions, and only 1 out of 55 showed malignancy (1.82%).

Also, we considered mean time to follow-up of the patients with BI-RADS 3. Mean time to follow-up is the period from initial diagnosis of BI-RADS 3 by imaging and outcome as either benign or malignant by tissue diagnosis or by imaging follow-up by protocol. For the majority of the patients (56.6%), the mean time follow-up was 6 months, followed by 12 months (18.18%), and the least (1.82%) a meantime follow-up of 24 months.

This signifies that most of the patient’s diagnosis was established before the completion of 24 months of imaging protocol either by histopathologically or downgradation of BI-RADS from the previous imaging.

Many patients underwent histopathological correlation even though imaging protocol did not warrant this, but it was done due to significant patient anxiety. Forty-six out of 55 patients (83.63% of patients) underwent histopathology.

SUMMARY AND CONCLUSION

Short-term interval follow-up in BI-RADS category 3 patients is enough to detect early breast malignancy, and this will avoid unnecessary tissue diagnosis (invasive procedure) in benign lesions. In our study, the malignancy yield in the follow-up of BI-RADS 3 was 1.82% (<2%).

In short interval follow-up at 6 months, one lesion showed a suspicious feature (indistinct irregular margin) for which tissue diagnosis was warranted and turned out to be ductal carcinoma in situ. This signifies the importance of short-term interval follow-up in BI-RADS 3 lesions which will pick up early breast malignancy.

The role of biopsy (or FNAC) and excision in BI-RADS 3 is secondary to follow-up. Our study also emphasized that scrutinized short-interval follow-up (6 months, 12 months, and 24 months) should be strictly followed in all BI-RADS 3 patients.

Ethical consideration

Members of the Institutional Ethics Committee of JN Medical College and Hospital, Aligarh Muslim University, Aligarh, India, have reviewed the research protocol in its meeting held on September 4, 2020, and found it suitable. Accordingly, they have approved the proposed study on “BI-RADS 3 lesions in north Indian population—their outcome and how to proceed for the follow-up!” in its meeting held on September 4, 2020, communicated vide letter no. IECJNMC/419 dated October 19, 2020.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.