Purpose: The American College of Radiology has developed appropriateness criteria for breast imaging evaluation of pregnant and lactating women, though large studies investigating diagnostic imaging performance for pregnancy-associated breast cancer detection are lacking. The purpose of this study was to perform a systematic review of the literature of the diagnostic performance of breast imaging modalities for cancer detection in pregnant and lactating patients.
Materials and Methods: A systematic review of the literature was conducted using PubMed, Scopus, Web of Science, and Cochrane Library from the date of database inception until 03/03/2023. Details of the review protocol are registered with the International Prospective Register of Systematic Reviews (CRD42023398422). Studies were assessed for quality based on bias and applicability. True-positive, false-positive, true-negative, and false-negative values were recorded for each study and were used to calculate sensitivity, specificity, and 95% confidence intervals.
Results: Twenty-five studies published from 1992 to 2023 met the eligibility criteria. No studies were assessed as high risk of bias or low applicability. The studies were conducted across 13 countries with 6 studies from the United States and all used a retrospective design. The studies included a total of 1366 female patients with an average age of 33 years old. Eight studies included only lactating patients, 4 with only pregnant patients, and 13 studies included both populations. Ultrasound, mammography (primarily digital full-field), and MRI data were included in 24, 19, and 8 studies, respectively, with 19 multi-modality studies. Breast MRI was only performed for lactating patients since gadolinium-based contrast agents are not recommended during pregnancy. For ultrasound, overall sensitivity and specificity was 0.92 (95%CI: 0.89-0.94; 22 studies) and 0.76 (0.73-0.80; 7 studies), respectively. For mammography, overall sensitivity and specificity was 0.81 (0.77-0.84; 18 studies) and 0.94 (0.88-0.98; 3 studies), respectively. For MRI, overall sensitivity and specificity was 0.99 (0.95-1.00; 7 studies) and 1.00 (0.59-1.00; 2 studies), respectively.
Conclusion: Several studies demonstrate high sensitivity of ultrasound and MRI for the detection of pregnancy-associated breast cancer with moderate sensitivity of mammography. Data regarding specificity is limited since most studies only included patients with biopsy-proven malignancy. A meta-analysis is currently being performed.
Clinical Relevance Statement: Use of ACR appropriateness criteria is supported by the literature for breast imaging evaluation of pregnant and lactating patients. Future larger prospective studies are needed in both the diagnostic and screening settings and for assessing newer technologies, such as digital breast tomosynthesis and contrast-enhanced mammography.
