NCT02310698|Completed
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Sponsor study identifier
observational
487
1 country
1
Study Start
December 2, 2014
Actual (reported)Primary Completion
March 26, 2025
Actual (reported)Study Completion
March 26, 2025
Actual (reported)Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography. Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 26, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2014
Actual (reported)December 3, 2014
Actual (reported)December 8, 2014
Actual (reported)March 26, 2025
Actual (reported)March 26, 2025
Actual (reported)The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.
With respect to imaging, a positive test is defined by a recommendation for biopsy (BIRADS 4 or 5). Negative imaging tests are those with BIRADS 1-3. The number of recommendations for short term follow up (BI-RADS 3) will also be recorded.
1 year
* Women presenting for screening full field digital mammography (FFDM) and WBUS on the same day or within 30 days of one another. o These women will be offered CEDM instead of the FFDM. * Women that are scheduled for CEDM alone. o These women will be offered WBUS in addition to the CEDM. * Women scheduled for both CEDM and WBUS on the same day or within 30 days of one another.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MSKCC clinic
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Horvat JV, Amir T, Watt GP, Comstock CE, Nissan N, Jochelson MS, Sung JS. Comparison of Contrast-enhanced Mammography and Low-Energy Imaging with or without Supplemental Whole-Breast US in Breast Cancer Detection. Radiology. 2025 Mar;314(3):e242006. doi: 10.1148/radiol.242006.
Janice Sung, MD
Memorial Sloan Kettering Cancer Center
487 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2014
First Posted
December 8, 2014
Study Start
December 2, 2014
Actual (reported)Engaging Diverse Underserved Communities to Bridge the Mammography Divide
Contact the study team to confirm eligibility.
Primary Completion
March 26, 2025
Actual (reported)Study Completion
March 26, 2025
Actual (reported)Last Updated
March 28, 2025
Record last verified: 2024-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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