Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer
NCT ID: NCT03176979
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2017-04-21
2021-07-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (CESM with DBT)
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 IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes.
Contrast Agent
Given IV
Digital Tomosynthesis Mammography
Undergo CESM with DBT
Dual-Energy Contrast-Enhanced Digital Spectral Mammography
Undergo CESM with DBT
Interventions
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Contrast Agent
Given IV
Digital Tomosynthesis Mammography
Undergo CESM with DBT
Dual-Energy Contrast-Enhanced Digital Spectral Mammography
Undergo CESM with DBT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Women with renal failure or insufficiency
* Women with iodine contrast allergy
* Women with gadolinium contrast allergy
* Women who are pregnant, possibly pregnant, or lactating
* Women undergoing neoadjuvant chemotherapy
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Mary Yamashita, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2017-00778
Identifier Type: REGISTRY
Identifier Source: secondary_id
1B-16-3
Identifier Type: OTHER
Identifier Source: secondary_id
1B-16-3
Identifier Type: -
Identifier Source: org_study_id