RPS 1202 - Improving the clinical impact of contrast-enhanced mammography

Author Block: S. Marziali¹, A. Cozzi¹, M. Fanizza¹, V. Magni¹, L. Menicagli¹, A. Benedek¹, G. Di Giulio², F. Sardanelli¹; ¹Milan/IT, ²Pavia/IT
Purpose: To evaluate the diagnostic performance of contrast-enhanced mammography (CEM) for the assessment of screening recalls.
Methods or Background: Recalled women were prospectively enrolled at two centres to undergo CEM alongside standard assessment (SA) through additional views, tomosynthesis, and/or ultrasound between January 2019 and July 2021. Exclusion criteria were symptoms, implants, allergy to contrast agents, renal failure, and pregnancy. SA and CEM were independently evaluated by one of six radiologists, who recommended biopsy or ≥3-year follow-up. Diagnostic performance of CEM (low-energy plus recombined images) was calculated considering histopathology for lesions biopsied and/or surgically removed as well as ≥3-year follow-up for both breasts.
Results or Findings: Between January 2019 and July 2021, 220 women were enrolled, 207 of them (median age 56.6 years) with 225 suspicious findings, 135 of them referred for biopsy (4 by rCEM alone, 2/4 being one DCIS and one invasive carcinoma). During ≥3-year follow-up, 4 interval cancers were reported: one mucinous invasive carcinoma and one DCIS at the site of previous assessment with biopsy; one DCIS in a different quadrant of the same breast; and one invasive carcinoma NST at the contralateral breast (found at the third year after CEM). No woman was lost at follow-up. The overall CEM performance was: sensitivity 80/84 (95.2%, 95% CI 88.3−98.7%); specificity 108/123 (87.8%, 95% CI 80.7−90.3%9).
Conclusion: The role of CEM in the assessment of recalls is confirmed at over 3-year follow-up in terms of both sensitivity and specificity. The two cases of interval cancers at the site of previous biopsy highlight the need of radiologic-pathologic correlation.
Limitations: Limited sample size.
Funding for this study: GE Healthcare
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: San Raffaele Hospital, Milan, Italy

Author Block: G. Vatteroni¹, N. Turri¹, F. Fici¹, M. Filippini², N. Basla³, G. Pinna¹, G. Pruneddu¹, R. M. Trimboli¹, D. Bernardi¹; ¹Milan/IT, ²Brescia/IT, ³Pavia/IT
Purpose: To present interim results from the 'COMBO TRIAL, a prospective intraindividual study evaluating the performance of Contrast-Enhanced Mammography(CEM) vs Digital Mammography(DM) for the surveillance of women with a personal history of breast cancer(BC).
Methods or Background: Between January 2023 and April 2024, women who underwent breast-conserving surgery for BC were invited to undergo CEM for routine surveillance. Exclusion criteria included: suspicious symptoms of BC, allergy to iodinated contrast agents, renal failure, breast implants. For each patient, one reader reported CEM while a second reader, independent and blinded, evaluated only LE images equivalent to DM. The reference standard was 1-year follow-up for negative cases and biopsy/surgery for BI-RADS 4/5. Cancer Detection(CD) rate for both DM and CEM and incremental CD rate for CEM, sensitivity, specificity, PPV, NPV and accuracy were calculated. We evaluated differences in diagnostic performance between DM and CEM using McNemar test(p<0.05 significant).
Results or Findings: Overall, 600 women were included in the analysis with a recall rate of 9.8%. Among them, 14 cases of BC were detected: 8 (5 DCIS +3 invasive) were identified by both DM and CEM, while CEM detected 6 additional cases (1 DCIS+5 invasive). Three cases were missed by both DM and CEM but subsequently detected by US, resulting in a global recurrence rate of 2.8%. The CD rate for CEM was 23 per 1000, compared to 13 per 1000 for DM, indicating an incremental CD for CEM of 10 per 1000 (p=0.014). Compared to DM, CEM demonstrated significantly higher sensitivity(82.4% vs. 47.1%), slightly lower specificity(96.4% vs. 97.6%), slightly higher PPV(40.0% vs. 36.4%), slightly higher NPV(99.5% vs. 98.4%), and similar accuracy(96.0% vs. 96.2%).
Conclusion: Implementation of CEM in BC surveillance was associated with a significant increased detection of invasive cancers.
Limitations: n/a
Funding for this study: this study received research support by Siemens Helthineers
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: The ethics commitee approved this study

Author Block: M. Conti, R. Rella, S. Palma, S. Amodeo, N. Di Cataldo, D. Moretti, M. Costantini, O. Tommasini, P. Belli; Rome/IT
Purpose: Aim of the study is to assess the performance of Lesion Conspicuity (LC) in Contrast Enhanced Mammography (CEM) in the prediction of malignancy.
Methods or Background: This is an observational retrospective study involving 153 women (median age, 44.1 years, IQR: 36-52) who underwent CEM and subsequent histological assessment at Policlinico Universitario A. Gemelli IRCCS (April 2021-October 2023). Two radiologists (with 2 and 7 years of experience in breast imaging, independently) evaluated low-energy (LE) images and LC (categorizing it as absent, low, moderate or high) and assigned a BIRADS category of suspicion to the lesion basing on both. Diagnostic performance of LE images and LC interpretation together was calculated using histological results of the biopsy as gold standard. Subgroup analyses based on mammographic breast density, background parenchymal enhancement (BPE) on CEM and type of lesions were also performed.
Results or Findings: The interpretation of LE images together with the value of LC showed a sensitivity (SE) of 96.8% (95%CI: 92.1%-99.1%) and a specificity (SP) of 66.7% (95%CI: 46.0%-83.5%) vs. a SE=90.7% (95%CI: 82.5%-95.9%) and a SP=52.6% (95%CI: 28.8%-75.5%) for LE images evaluation alone. Diagnostic performance of LE images + LC evaluation was better than LE images alone both in dense (SE=96.4% and SP=89.8% vs. SE=93.3% and SP=60.0%) and adipose (SE=97.3% and SP=66.7% vs. SE=89.3% and SP=44.4%) breasts. Diagnostic performance of LE images + LC evaluation is better than LE images alone both in minimal/mild and moderate/marked BPE and in all types of lesions.
Conclusion: The evaluation of LE images joint with the value of LC demonstrated a better performance than LE images alone in predicting the malignancy of lesions.
Limitations: Limitations of the present study include its retrospective and monocentric design.
Funding for this study: No funding was received for this study.
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: The study was approved by the local Institutional Review Board (ID: 6476)

Author Block: M. Balbino¹, F. Masino², M. Montatore³, S. Suriano⁴, F. A. Carpagnano⁴, G. Capuano³, G. Guglielmi⁵; ¹Triggiano/IT, ²Bari/IT, ³Barletta/IT, ⁴Foggia/IT, ⁵Andria/IT
Purpose: To evaluate the diagnostic accuracy of CEM in detecting and measuring breast tumors, comparing it with histological findings.
Methods or Background: This study evaluated the diagnostic accuracy of Contrast-Enhanced Spectral Mammography (CEM) in 69 breast cancer patients treated at the “Santa Maria” Hospital (Bari, Italy) from January 2018 to September 2023. Patients ranged from 33 to 86 years old, with an average age of 55.8 years. All underwent CEM and subsequent biopsy or cytology for confirmation. Exclusion criteria included deep lesions, post-biopsy hematomas, or renal insufficiency. CEM was performed using a GE Healthcare system with two post-injection projections: Cranio-Caudal and Medio-Lateral-Oblique. Three experienced radiologists analyzed the scans, comparing lesion sizes from mammography, CEM, and histology.
Results or Findings: Results showed that CEM underestimated lesion size in 28 cases, while mammography did so in 21. CEM identified 92.3% of multifocal masses, compared to 58.3% with mammography. In histology, 49.27% of patients had mass-like neoformations, with 33.3% showing homogeneous contrast enhancement. High contrast enhancement correlated with higher Ki67 proliferation indices (50-65%). The majority of neoplasms were Infiltrating Ductal Carcinomas.

Statistical analysis revealed that CEM was more accurate than mammography, with the Wilcoxon signed-rank test showing no significant difference between CEM and histological measurements (p=0.9928). CEM showed high diagnostic accuracy in preoperative staging, supporting its use over MRI, particularly due to its lower cost, faster acquisition time, and better patient tolerance. The study concludes CEM is a valuable, cost-effective alternative to MRI for assessing tumors before surgery, particularly in preoperative staging and the identification of multifocal lesions.
Conclusion: CEM demonstrated high accuracy in assessing breast tumor size and extent, proving to be a valid alternative to MRI due to its lower cost, faster acquisition time, and better patient tolerability.
Limitations: No
Funding for this study: No
Has your study been approved by an ethics committee? Not applicable
Ethics committee - additional information: No

Author Block: A. Santonocito, T. H. Helbich, P. Clauser, P. A. Baltzer; Vienna/AT
Purpose: Microcalcifications are frequently observed in screening mammography, with malignancy rates ranging from 6% to 82%. Their characterization and work-up are a major challenge for the radiologist. This study aimed to assess the role of contrast-enhanced mammography (CEM) in managing microcalcifications.
Methods or Background: This retrospective, single-centre, IRB-approved, study included consecutive patients underwent CEM for BI-RADS 4 microcalcifications between October 2018 and September 2024. Patients without a standard of reference were excluded. The standard of reference was histology from biopsy or surgery, or a one-year follow-up for non-suspicious cases. Morphology, distribution, density, and density heterogeneity of microcalcifications were assessed on LE images; enhancement type and lesion conspicuity were assessed on RC images according to the CEM lexicon. Microcalcification and enhancement characteristics were analysed through Spearman correlation and chi-square tests to evaluate associations with histological outcomes.
Results or Findings: A total of 210 lesions in 197 patients (mean age 55 ±11 years old) were analysed. Of these, 124 (63%) were benign and 72 (37%) were malignant. Lesion conspicuity correlated with morphology (r=0.429), pleomorphism (r=0.514), distribution (r=0.235), and density heterogeneity (r=0.204), while no correlation was found with density (r=-0.111). Chi-square test showed significant differences between benign and malignant calcifications for lesion type (p<0.001), morphology (p<0.001), grade of pleomorphism (p<0.001), distribution (p<0.001), density (p<0.001), enhancement type (p<0.001), lesion conspicuity (p<0.001) and grade of density heterogeneity (p=0.02). No significant differences were found for size (p>0.05).
Conclusion: Our findings suggest that CEM may help differentiate between benign and malignant microcalcifications, potentially reducing unnecessary biopsies.
Limitations: Retrospective study; small cohort
Funding for this study: None
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: Number: 1391/2022

Author Block: S. Vidali, F. Di Naro, D. De Benedetto, G. Bicchierai, E. Vanzi, C. Bellini, C. Boeri, V. Miele, J. Nori; Florence/IT
Purpose: Among contrast-enhanced mammography (CEM)'s indication, is the evaluation of locally advanced breast cancer(LABC)'s response to neoadjuvant therapy (NAT). CEM has potential not only in the assessment of radiologic complete response (rCR) but also in predicting tumour response based on biological features and enhancement patterns.
Methods or Background: We retrospectively analysed post-NAT CEMs of 141 patients diagnosed with LABC between 2016-2024 and correlated enhancement patterns (rCR, residual enhancement, RE) with diagnostic biopsy biologic features and post-surgical pathology data (pCR, residual disease RD).
Results or Findings: CEM showed RE in 92 patients (68 with RD and 24 with pCR) was negative in 49 (17 with RD and 32 with pCR), with resulting mean sensitivity of 80% and specificity of 57%. Reclassifying DCISs as RD instead of pCR, specificity raised to 65%: these performance data are adequate and comparable to those reached by CE-MRI, the gold standard. Based on biological subtypes, distinct enhancement patterns resulted coherent with the expected therapeutic responses: luminal A tumours (46 patients) were less responsive to NAT (11% pCR, 5 patients, 4 of them with rCR, 80%), while HER2+ (37 patients) and triple negative(TN)BCs (20 patients), the more aggressive forms were more likely to achieve pCR and rCR: respectively 59% pCR (22 patients) in the HER2+ group of which 64% (14 patients) with rCR, 50% pCR in the TNBCs (10 patients) of which 60% (6 patients) with rCR. Luminal B lesions (38 patients) achieved pCR in 45% of cases (17 patients) of which 13 with rCR (76%).
Conclusion: CEM is adequate and reliable in assessing disease response to NAT: enhancement patterns demonstrated correlation with biological features, forecasting CEM’s potential as a prognostic and management tool for increasing conservative therapies and diagnostic follow-up.
Limitations: Sample's numerosity and heterogeneity.
Funding for this study: No funding was received for this study.
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: Regione Toscana, Comitato Etico Area Vasta Centro, reference number: SPE_16.251

Author Block: J. M. Net, J. Spoont, S. Stamler, C. Pluguez-Turull, N. Brofman, A. Hamedi-Sangsari, M. Yepes; Miami, FL/US
Purpose: To determine outcomes of screening Contrast Enhanced Mammography (CEM) in women with BI-RADS density 3 or 4, more specifically to determine outcomes of CEM in this population who did not undergo screening breast ultrasound.
Methods or Background: HIPAA compliant and IRB approved retrospective study evaluated all medical records of patients who underwent CEM at our institution between 8/2019-8/2024. Reports were reviewed and scored for breast density, additional work up (additional imaging, US, MRI), final BI-RADS, biopsy results and whether target represented CEM finding, if high risk lesion or malignant case was scored based on final surgical pathology. Final results were tallied to include overall CDR, PPV3, and interval cancer rate.
Results or Findings: 1215 CEM studies were performed between 2020-2024, 1079 were performed for screening of which 740 were assigned BIRADS density 3 or 4. 87 patients (11.7%) were referred for additional work up including US in 75, and MRI in 12. Of these, 46 were referred for biopsy which confirmed malignancy in 16 patients translating into a CDR of 21.6/1000 and PPV3 of 35.5%. Of the remaining 653 patients (88.2%) without additional work up, 46 underwent annual MRI within 12 months of CEM confirming the only 2 interval cancers in this study (0.3%), one stage 0 DCIS/linear 1.3 cm NME on staggered 6 month MRI and the other a 1.2 cm TNBC (T1Nitc) on staggered 6 month MRI - neither was seen in retrospect.
Conclusion: The low interval cancer rate combined with high CDR suggest that CEM screening in women with dense breasts can potentially replace supplemental breast US for adjunct screening.
Limitations: Limitations include modest sample size, retrospective design, and inclusion of cases from a single institution which limits generalizability.
Funding for this study: None
Has your study been approved by an ethics committee? Yes
Ethics committee - additional information: IRB approved study.