Comparison study between stereotactic versus digital breast tomosynthesis-guided core needle biopsy

Introduction

The increasing implementation of digital breast tomosynthesis (DBT) in clinical practice has improved the effectiveness of screening and diagnosis (1-10). DBT preserves all diagnostic information available from digital mammography (DM) while providing additional imaging findings. This technique utilizes multi-angle image acquisition for precise breast imaging. A series of low-dose tomosynthesis projection images is obtained as the X-ray tube rotates at various angles across an arc through the breast; these projection images are reconstructed to create three-dimensional (3D) images, reducing the effect of tissue overlap and improving visualization of abnormalities (11). Consequently, DBT-guided biopsy is not only applicable to lesions detected on DM, but demonstrates particular advantages for abnormalities best visualized with DBT. For lesions detected exclusively on DBT, DBT-guided biopsy serves as a reliable and direct method to sample suspicious breast abnormalities without a sonographic correlate. These abnormalities include microcalcifications, masses, asymmetries, and architectural distortions. Some previous reports have suggested that DBT-guided vacuum-assisted biopsy (VAB) involves shorter procedure times and lower exposures than stereotactic (ST)-guidance (12-17). However, in most studies, DBT-guided biopsies were performed by VAB; limited data have been published regarding DBT-guided core needle biopsy (CNB), and there have been few studies in Chinese women. With this in mind, the primary objective of our present study was to compare the performance and outcomes of DBT and ST-guided CNB in Chinese women. We present this article in accordance with the STROBE reporting checklist (available at https://qims.amegroups.com/article/view/10.21037/qims-2025-9/rc).

Methods

Clinical data

This study included only mammography-guided CNB procedures. We performed a search of our mammography reporting system in the Picture Archiving and Communication System (PACS) for all CNB between August 2021 and July 2024. Procedures with missing images in our PACS were excluded. We performed ST-CNB on 80 patients (100 lesions; median age, 49 years; age range, 27–67 years) from August 2021 to August 2023. From September 2023 to July 2024, we performed 134 DBT-CNB procedures in 96 patients. The median age of the patients was 48 years (range, 32–73 years). The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of The Fourth Hospital of Hebei Medical University (No. 2024ky228) and informed consent was provided by all individual participants. In our institution, all diagnostic mammograms were performed with DBT, which routinely included bilateral craniocaudal and mediolateral oblique mammograms.

Procedures and devices

The American GE Pristina Hygeia mammography machine, which has a sweep angle of 25 with 9 projections, was used for DBT-guided CNB, and GE Senographe Essential was used for ST-guided CNB. All biopsies were performed using the 16-gauge spring-loaded needle device with a 15 mm penetration depth (Bard-Magnum Biopsy Instrument; Becton, Dickinson and Co., Franklin Lakes, NJ, USA). All patient biopsies were performed in an upright position on a dedicated armchair. Throughout the study period, at least 3 biopsy fragments were collected in each case, and all fragments were usually obtained in a clockwise direction. Prior to the biopsy, the mediolateral positions were routinely applied and all patients’ images were reviewed by the radiologist and radiographer to plan breast positioning and the shortest direction of approach to the lesions. For DBT-guided CNB, lesions were targeted according to the best visibility on a DBT slice and the most suspicious was selected using a cursor, then the system software automatically calculated the lesion coordinates and depth information (Figure 1). For ST-guided CNB, triangulation was required, utilizing three two-dimensional (2D) images (0±15 °) to determine the lesion’s X, Y, and Z-axis location (Figure 2). Due to the technical difficulty of the biopsy gun and gantry shielding and to conserve time, we do not have conventional pre-fire images. All of the biopsied fragments with or without calcifications were submitted to radiography. For calcified lesions, this procedure allows for clear identification of calcification within the fragments. In addition, it enables precise time recording in the PACS system, where the acquisition time of the biopsied fragment image was designated as the endpoint for biopsy procedure; meanwhile, it enables recording of relevant fragments’ information (such as the number of fragments and the length of each sampled fragment) for future review. Since radiography of the fragments does not cause additional radiation exposure to patients, our institution routinely performs radiological imaging on all fragments.

Figure 1 A case of a patient who underwent DBT-guided biopsy. Imaging review of a 55-year-old woman revealed architectural distortion (arrows) in the upper inner quadrant of the right breast on DBT, including the (A₁) CC, (A₂) MLO, and (A₃) ML views. Sonographic correlation suggested associated glandular thickening in the same area. (B) DBT-guided CNB was performed on the most visible slice in the ML view. The biopsy revealed grade 2 invasive lobular carcinoma, a concordant finding that was subsequently confirmed by surgical excisional biopsy. CC, craniocaudal; CNB, core needle biopsy; DBT, digital breast tomosynthesis; ML, mediolateral; MLO, mediolateral oblique.

Figure 2 A case of a patient who underwent ST-guided biopsy. A 43-year-old woman had regional amorphous microcalcifications in the upper outer quadrant of left breast, was recommended for biopsy. There was no sonographic correlate for the finding. (A,B) 2D images of the left breast, in CC and MLO views, with their respective locally enlarged images (A₂,B₂); (C) three 2D images (0±15 °)—specifically, (C₁) at 0, (C₂) at −15 °, and (C₃) at +15 ° to determine the microcalcification’s X, Y, and Z-axis location in ST-guided CNB; the ST-CNB showed adenosis, and subsequently she underwent ST-guided wire localization resection: adenosis, with FEA of the regional ductal epithelium. The arrows indicated the regional amorphous microcalcifications in lesions area. 2D, two-dimensional; CC, craniocaudal; CNB, core needle biopsy; FEA, flat epithelial atypia; MLO, mediolateral oblique; ST, stereotactic.

Histopathological categories

All biopsy fragments were routinely fixed in formalin and submitted for routine processing. Further immunohistochemical studies were performed in cases where definitive diagnosis of stromal invasion was difficult. The histopathology of biopsy fragments was classified into five categories (B1, normal tissue; B2, benign lesion; B3, lesion with uncertain malignant potential; B4, suspicious of malignancy; and B5, malignant) according to the recommendations of European guidelines for quality assurance in breast cancer screening and diagnosis (18-20). B3 lesions include atypical ductal hyperplasia (ADH), flat epithelial atypia (FEA), papillary lesions such as intraductal papilloma (IDP), atypical lobular hyperplasia (ALH), and so on. B4 category is used uncommonly, mostly for small fragments of atypical cells separate from the main core, focal atypical intraductal proliferations that are insufficient for confident diagnosis of ductal carcinoma in situ (DCIS), or very small foci of invasive carcinoma in which there is insufficient material to allow immunohistochemical studies for a definite diagnosis. The B5 category is further subdivided into B5a, B5b, and B5c. B5a comprises DCIS and lobular carcinoma in situ. B5b includes all invasive breast carcinomas, such as invasive ductal carcinoma, invasive lobular carcinoma, and so on. B5c should be applied rarely, as this category is used only when it is not possible to tell whether the carcinoma is invasive or in situ (18-20).

Radiologists

During the study period, 4 breast radiologists interpreted all imaging assessments and performed mammographically-guided biopsies. Each radiologist had a minimum of 5 years of clinical interventional operation experience.

Data collection and analysis

Patient breast density, biopsy target type, the largest diameter in centimeters of lesion, the number of biopsy fragments obtained, compressed breast thickness in millimeters, procedure time (subtract the time on the first targeting lesion image from the time on the final obtain the biopsied fragments image), the number of image exposures obtained, average glandular dose (AGD) overall procedure, AGD per acquisition, radiologic-pathologic concordance and discordance, pathologic results from 16-gauge CNB, and pathologic results of surgical excision (when available) were recorded. The pre-operative CNB diagnosis and subsequent excisional diagnosis were analyzed to calculate the concordance and upgrade rates. The CNB results and surgical pathologic findings were considered in concordance in the following situations: B2 results at CNB and either B2 or B3 lesion at surgery; B3 lesion at CNB and either B2 or B3 lesion at surgery; B4 lesion at CNB with DCIS (B5a) at surgery (21); DCIS lesion at CNB and surgery; invasive cancer or other malignant lesion at CNB and surgery. Upgrade rate refers to the number of patients whose B classification of surgical pathology results was higher than that of biopsy results, divided by the number of biopsy patients. Notably, both transitions between B2/B3 categories and B4→B5a progression are considered concordance rather than upgrade, as these changes do not reflect malignant progression. This approach ensures the upgrade rate accurately reflects critical diagnostic discrepancies that genuinely impact patient management. Based on the 5th edition of the Breast Imaging Reporting and Data System (BI-RADS) (22), breast density was classified into the following categories: (a) almost entirely fat; (b) scattered areas of fibroglandular tissue; (c) heterogeneously dense; (d) extremely dense; categories (a) and (b) were considered non-dense, and categories (c) and (d) were considered dense. In our study, BI-RADS 1–3 were considered benign, and BI-RADS 4A–5 were considered malignant. BI-RADS greater than 4A requires clinical intervention and some BI-RADS 3 patients with previous history of breast cancer, family history, or contralateral breast cancer also performed biopsy.

Statistical analysis

The software SPSS 27.0 (IBM Corp., Armonk, NY, USA) was used for data analysis. Shapiro-Wilk test was used to determine whether the data conformed to normal distribution, and Mann-Whitney U test was used to compare the continuous measurement data when the data were not in line with normal distribution. Measures were compared between ST- and DBT-guided biopsies using Mann-Whitney U test or 2-sample t-test for continuous variables and Chi-squared test or Fisher’s exact test for categorical variables. P values <0.05 were considered statistically significant. All statistical tests were 2-sided.

Results

Biopsy characteristics

In total, 234 biopsies were obtained in 174 women (42.7%, 100/234 with ST and 57.3%, 134/234 with DBT). A total of 100 breast CNB in 80 women (20 patients had 2 lesions) were performed using ST-guided and 134 (94 patients, 36 patients with 2 lesions and 2 with 3 lesions) were performed using DBT-guided CNB. In the ST group, 96 of 100 (96.0%) had dense breast tissue, and in the DBT group, 127 of 134 (94.8%) had dense breast tissue (P=0.253). There were no differences in calcification morphology (P=0.745), calcification distribution (P=0.055), and biopsy outcome (P=0.433) between the 2 groups. The DBT group had a higher proportion of biopsies for non-calcified lesions: 26.1% of DBT-guided CNB were performed for such lesions, compared with 12.0% in the ST group (P=0.008; Table 1).

Biopsy outcomes

The procedure time was shorter with DBT-guided CNB (571.0 [484.0–716.5] vs. 827.0 [712.5–968.5] s) (P<0.001). The number of image exposures was significantly lower for DBT-guided (1 [1–2]) than ST-guided (3 [3–3]) CNB (P<0.001). The AGD overall procedure for DBT-guided CNB was (2.09 [1.75–2.98] mGy). The AGD overall procedure for ST-guided CNB was (7.39 [6.23–8.09] mGy). There was a significant difference between the AGD overall procedure (P<0.001). The AGD per acquisition was lower for DBT-guided than it was for ST-guided (1.89 [1.56–2.09] vs. 2.43 [2.10–2.72] mGy) CNB (P<0.001). For the largest diameter of lesion, the ST group was larger than DBT (3.0 [1.4–5.8] vs. 2.05 [0.7–4.3] cm) (P=0.004). For the number of biopsy fragments obtained, the ST group was lower than the DBT group (4.0 [3.0–4.0] vs. 4.0 [4.0–5.0]) (P=0.001).

In the ST-guided CNB group, surgical excisions were available for 58 (58.0%) of the 100 lesions; subsequent surgical excision revealed 19 upgrades (32.8%; 19 of 58) as follows: B2 to B5a in two patients, B2 to B5b in three patients; B3 to B5a in four patients, B3 to B5b in seven patients, and B5a to B5b in three patients. In the DBT-guided CNB group, surgical excisions were available for 71 (53.0%) of the 134 lesions; subsequent surgical excision revealed 22 upgrades (31.0%; 22 of 71) as follows: B2 to B5a in three patients, B2 to B5b in one patient, B3 to B5a in six patients, B3 to B5b in three patients, and B5a to B5b in nine patients. The upgrade rates were not different in different B categories between the two groups (P>0.05) (Tables 2-4), and there was no statistical difference in the upgrade rate of DCIS among patients with or without calcification lesions in the ST and DBT groups (P>0.05). The largest diameter of calcified lesion was a predictive factor of invasion in B5a patients (all B5a concordant: 3.58±2.47 cm, B5a upgrade: 6.72±3.14 cm, P=0.016).

Biopsy complications

Only minor complications were encountered in both systems. Five patients who underwent ST-CNB and four patients who underwent DBT-CNB developed vasovagal reactions, which were self-limited (P=0.502).

Discussion

We confirmed the superiority of DBT-CNB over ST-guided CNB in a statistically significantly lower time in our study. Triangulation, which was a process for the same focal center of the targeting lesions in ST-CNB, needs two 2D images with ±15 ° of X-ray tube rotation to calculate depth. In order to confirm the coordinates of target lesions, three 2D images of 0 and ±15° were used for ST-guided biopsy. As for DBT-guided CNB, lesions were targeted in the best visible DBT slices and where the center of the most suspicious area was selected using a cursor, then the system software automatically calculated the lesion coordinates, resulting in quick and accurate targeting, so target images were all obtained with one or two DBT images (only two images were needed to avoid vessels intervention). Triangulation may fail to identify the same focal center in a pair of 15° images; this miscalculation results in a new pair of images being acquired, whereas DBT-guided CNB not only avoids such problems but also saves the time of patients undergoing mammographic-guided breast biopsy.

DBT-guided biopsy resulted in significantly lower procedure exposures. At our research facility, ST-CNB required at least three 2D images, whereas DBT-CNB usually only required one DBT image. The AGD per acquisition was lower for DBT-guided than for ST-guided CNB. As a matter of fact, the reduction of the number of exposures and AGD per acquisition will inevitably reduce the overall AGD procedure. In multiple previous studies, DBT-guided was associated with fewer exposures, which was similar to our results (11,13,15,16,23).

Another advantage of DBT-guided CNB was a higher proportion of biopsies for non-calcification lesions, which was also previously reported by investigators on DBT-guided VAB (15,24-26). In our study, 26.1% of DBT-guided CNB were performed for non-calcification lesions, compared with 12.0% of ST-guided biopsy (P=0.008).

Lastly, as it is generally known, concordance rate and upgrade rate vary widely in the literature; all breast cancers with biopsy results of B2 in both groups of CNB were associated with radiologic-pathologic discordance; for this reason, these patients all underwent subsequent surgery, which may not represent under-management of mammographic detected breast lesions. The upgrade rates (from CNB to postoperative diagnosis) were 90.9% (10/11) for ADH lesions in the ST group and 50.0% (6/12) in the DBT group. Current evidence confirms that ADH exhibits the highest malignant upgrade rate, ranging from 3% to 65%, with VAB demonstrating a lower upgrade rate (approximately 30%) than CNB; surgical excision remains standard regardless of diagnostic modality (27-43). Of course, all ADH lesions in our cohort ultimately underwent surgical excision, including three cases that had been referred to external institutions for completion of care. The upgrade rates for non-ADH B3 lesions were 33.3% (1/3) in the ST group and 75.0% (3/4) in the DBT group. Our study demonstrated significantly higher upgrade rates compared to published benchmarks, particularly for ADH lesions in the ST group (90.9% vs. literature range 3–65%) and non-ADH B3 lesions in the DBT group (75.0% vs. expected <50%) (27-36). Three factors may explain this discrepancy: first, the overall sample size of B3 lesions was relatively small (ST group: n=14; DBT group: n=16), with particularly limited cases of non-ADH subtypes (only 3 cases of IDP/FEA in the ST group and 4 cases of IDP/ALH in the DBT group) (Figure 3). This may also relate to our predominantly calcified lesion population, which could affect subtype representation. This imbalanced subtype distribution may introduce bias in upgrade rate assessment. Future studies with expanded cohorts, especially for non-ADH subtypes, are needed to validate these findings. Second, not all patients opted for further immunohistochemical studies, which resulted in inconsistent biopsy and surgical results. Third, with reference to a previously published study (44), it was expected that the needle gauges would have influenced malignancy upgrade rates; most of the gauges used in prior articles were 7-, 8-, 9-, 11-, and 14-gauge vacuum probes or 14-gauge core needles, which were larger than the needle gauges in our hospital. According to data in the existing literature, the upgrade rate of B5a by CNB ranges from 0 to 59%, and the upgrade rate of B5a was significantly lower in VAB than CNB group (45-48). The upgrade rate of B5a lesions in ST group was 30.0% (3/10 cases) and DBT group was 52.9% (9/17 cases) in our present study (P=0.424). These results were consistent with previous studies. Although there were more non-calcified lesions in the DBT group than there were in the ST group, there was no statistical difference in the upgrade rate of DCIS among patients with or without calcified lesions in the ST and DBT groups, which was similar to the report by Lamb et al. (49). Interestingly, Han (50) and Liu (51) revealed that there was a statistical difference in the upgrade rate of B5a, where those with calcification were less likely to be diagnosed with invasive carcinoma as compared with those without calcification. More data may be needed to confirm this in the future. In addition, some authors have proposed the extent of microcalcification, such as Maffuz et al. (52) with microcalcification >2.5 cm, and Yen et al. (53) with ≥4 cm, Zhang et al. (54) ≥2.7 cm, and Renshaw et al. (55) with >4 mm, as a predictive factor of invasion, in contrast to a substantial proportion of published data, Wahedna et al. (56). In line with this concept, our study found that the largest diameter of microcalcification was significantly larger in B5a lesions upgraded to invasive carcinoma (6.72±3.14 vs. 3.58±2.47 cm, P=0.016, Table 5).

Figure 3 Number of cases in B3 subgroup of DBT and ST group. ADH, atypical ductal hyperplasia; ALH, atypical lobular hyperplasia; DBT, digital breast tomosynthesis; FEA, flat epithelial atypia; IDP, intraductal papilloma; ST, stereotactic.

There were some limitations in this retrospective study. First, all biopsies were performed at a single tertiary breast center, which limits the generalizability of the results. Second, because biopsy systems were not randomized, different systems were used for guidance during different time periods, so the results of comparison of two groups may have biases. Third, the limited number of cases and subtype variety in B3 lesions may affect the reliability of upgrade rate estimation for this category, and future studies with expanded cohorts are needed to evaluate upgrade rate of B3 categories. Furthermore, we lack surgical resection and 2 years of imaging follow-up for all the patients who have been biopsied; this limitation might have influenced our overall upgrade and concordance rate. Further studies are needed to evaluate upgrade rate of different B categories.

Conclusions

DBT-guided CNB obtained breast suspicious lesions faster and with significantly lower radiation exposure compared to ST-guided CNB. We have provided evidence on transforming from ST-guided to DBT-guided CNB as feasible and accurate sampling methods. With a view to the future, VAB outperformed CNB with a lower disease upgrade rate. Therefore, VAB is the most urgent transformation for our institution.

Acknowledgments

The authors would like to express their gratitude to all those who helped them during the writing of this thesis.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://qims.amegroups.com/article/view/10.21037/qims-2025-9/rc

Data Sharing Statement: Available at https://qims.amegroups.com/article/view/10.21037/qims-2025-9/dss

Funding: This work was supported by the Medical Science Research Project of Hebei (grant No. 20241566).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-2025-9/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the ethics committee of The Fourth Hospital of Hebei Medical University (No. 2024ky228) and informed consent was obtained from all individual participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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