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Emerging Tools in the Detection of Breast Cancer: Comparison of Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis to Conventional Imaging Techniques Including Contrast Enhanced Magnetic Resonance Imaging and 2D Mammography With or Without Targeted Ultrasound
This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.
PRIMARY OBJECTIVES: I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional \[D\], magnetic resonance imaging \[MRI\], contrast enhanced spectral mammography \[CESM\], 3D) to gold standard index lesion size from surgical pathology (the largest diameter). II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above. OUTLINE: Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes. After completion of study, patients are followed up within 24-96 hours.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Start Date
April 21, 2017
Primary Completion Date
July 8, 2021
Completion Date
July 8, 2021
Last Updated
November 18, 2021
43
ACTUAL participants
Contrast Agent
OTHER
Digital Tomosynthesis Mammography
PROCEDURE
Dual-Energy Contrast-Enhanced Digital Spectral Mammography
PROCEDURE
Lead Sponsor
University of Southern California
Collaborators
NCT04704661
NCT05673200
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