Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT05667532
Brief Summary:
To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts
Detailed Description:
Primary Objectives:
* To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography.
* To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584.
Secondary Objectives:
* To perform within-subject comparison of the cancer detection rate between CEM and FFDM.
* To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts.
* To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT.
* In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT.
Exploratory Objectives:
* To combine imaging, blood biomarkers, health measurements and questionnaire data for assessment of breast cancer risk.
* To evaluate if the intensity of background parenchymal enhancement on CEM predicts breast cancer risk in women with dense breasts.
* To evaluate if patients consider CEM as a potentially acceptable imaging modality for routine breast cancer screening.
Study:
NCT05667532
Study Brief:
Protocol Section:
NCT05667532