N/A
Completed N=89
Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion
Source: ClinicalTrials.gov NCT05036083 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts. — 41.4 % of malignancy in new CEM lesions
Summary
This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts. |
41.4 | — |
| SECONDARY Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth. |
164; 126; 32; 6; 20; 103 | — |
| SECONDARY Percentage of Lesions That Appeared Larger on CEM |
28 | — |
| SECONDARY Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging |
68; 50; 3; 0; 11; 27 | — |
| SECONDARY Rate of Malignancy |
16; 82; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging
- Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC)
- Willingness to participate in the study and ability to provide informed consent
Exclusion Criteria
- Breast surgery within 6 months
- Known allergy to iodine-containing contrast agents
- History of anaphylactic reaction to any substance that required hospitalization or IV placement
- Renal insufficiency; hyperthyroidism
- Detection of non-breast primary or metastatic cancer in the breast
Data sourced from ClinicalTrials.gov (NCT05036083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.