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Preoperative CEM improved malignant extent estimation but failed to meet 10% treatment change primary endpointNew imaging tool helps map the extent of breast cancer

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Key Takeaway
Note that while CEM improves malignant extent estimation accuracy, it did not significantly change treatment plans.

This randomized controlled trial enrolled 415 women with early-stage breast cancer at two Swedish breast centers. The study compared preoperative Contrast Enhanced Mammography (CEM) against a standard of care control consisting of digital mammography, digital breast tomosynthesis, and ultrasound.

The primary outcome was a 10% change in treatment based on CEM findings. The study did not meet this primary endpoint, as 17 of 202 participants (8.4%) had treatment changes based on CEM findings (95% CI: 5.3, 13.1). Secondary outcomes showed no significant differences between the CEM and control groups for mastectomy rates (17% vs 18%, p = 0.78) or reoperation rates (7.9% vs 10%, p = 0.39).

Regarding malignant extent estimation, CEM showed the closest agreement with histopathologic malignant extent with a bias of 3.5 mm. This was superior to mammography/tomosynthesis (4.8 mm) and ultrasound (10.7 mm). No safety data or adverse events were reported. While CEM provides more accurate estimation of malignant extent than standard imaging, its impact on clinical management decisions was not statistically significant in this cohort.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in surgical planning for early-stage breast cancer. While previous coverage has focused on surgical techniques like nipple-sparing mastectomy and systemic therapies like trastuzumab botidotin, this study evaluates the role of preoperative imaging. It confirms that while CEM improves the accuracy of malignant extent estimation compared to mammography/tomosynthesis and ultrasound, it does not currently result in a significant change in treatment management for these patients.

When a woman is diagnosed with early-stage breast cancer, doctors must decide exactly how much tissue needs to be removed during surgery. Getting this map right is vital for the best possible outcome. A study in Sweden looked at a specific imaging tool called Contrast Enhanced Mammography (CEM) to see if it helps surgeons better estimate where the cancer ends and healthy tissue begins.

The study followed 415 women undergoing surgery. While the tool did not meet its primary goal of changing treatment plans in at least 10% of cases, it did show a specific advantage. The CEM imaging was more accurate at estimating the extent of the cancer than standard methods like mammography, tomosynthesis, or ultrasound.

Even though the imaging was more precise at mapping the cancer, the study found no difference in mastectomy rates or reoperation rates between the group using CEM and the group using standard care. Because the study was small and did not meet its primary goal, the results are specific to these measurements rather than a broad change in surgical practice.

What this means for you:
CEM imaging provides a more accurate map of cancer boundaries than standard imaging before breast surgery.

Common questions

How accurate is this new imaging technique?

The study found that Contrast Enhanced Mammography (CEM) showed the closest agreement with the actual tissue samples. It was more accurate at estimating the extent of the cancer than mammography, tomosynthesis, or ultrasound.

Does this new imaging change how many people need a mastectomy?

No. The study found no evidence of a difference in mastectomy rates between the group using the new imaging and the group using standard care. The rates were 17% for the CEM group and 18% for the control group.

Does this imaging reduce the need for follow-up surgeries?

The study found no evidence of a difference in reoperation rates between the two groups. The reoperation rate was 7.9% for those who had the new imaging and 10% for those who did not.

Study Details

Study typeRct
Sample sizen = 415
EvidenceLevel 2
Follow-up792.0 mo
PublishedNov 2026
View Original Abstract ↓
Background Contrast-enhanced mammography (CEM) is increasingly used in breast cancer diagnostics; however, randomized trials assessing the added value of CEM in preoperative staging of breast cancer beyond digital mammography, digital breast tomosynthesis, and US are lacking. Purpose To assess the added value of CEM for preoperative breast cancer staging in a randomized controlled trial. Materials and Methods This prospective randomized controlled trial (Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions) enrolled women diagnosed with early-stage breast cancer eligible for primary surgery at two breast centers in Sweden. Participants were randomized 1:1 to preoperative CEM or control from November 2020 through April 2024. The primary outcome was a 10% change in treatment due to preoperative CEM findings. Secondary outcomes included differences in reoperation and mastectomy rates between groups and accuracy of malignant extent estimation with CEM, mammography/tomosynthesis, and US using histopathologic extent as the reference, assessed with Bland-Altman statistics and concordance analysis. Subgroup analyses were performed according to menopausal status, breast density, histopathologic type of cancer, lesion size, and presence of microcalcifications at baseline imaging. Results In total, 415 participants (median age, 66 years; IQR, 56-73 years) completed the trial: 202 in the CEM group and 213 in the control group. Treatment was changed in 17 of 202 participants (8.4%; 95% CI: 5.3, 13.1) based on CEM findings. No evidence of differences was observed between the CEM and control groups with regard to mastectomy (17% [35 of 202] vs 18% [39 of 213]; = .78) or reoperation (7.9% [16 of 202] vs 10% [22 of 213]; = .39) rates. CEM showed the closest agreement with histopathologic malignant extent (bias, 3.5 mm), outperforming mammography and/or tomosynthesis (4.8 mm) and US (10.7 mm) overall and in nine of 10 predefined subgroups, except for ductal carcinoma in situ. Conclusion This trial did not meet its primary end point of a 10% treatment change; however, preoperative CEM improved malignant extent estimation. ClinicalTrials.gov: NCT04437602 © The Author(s) 2026. Published by the Radiological Society of North America under a CC BY 4.0 license. See also the editorial by Mesurolle and El Khoury in this issue.
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