Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03176979|
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma||Other: Contrast Agent Procedure: Digital Tomosynthesis Mammography Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 21, 2017|
|Estimated Primary Completion Date :||April 21, 2020|
|Estimated Study Completion Date :||April 21, 2021|
Experimental: 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.
Other: Contrast Agent
Procedure: Digital Tomosynthesis Mammography
Undergo CESM with DBT
Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography
Undergo CESM with DBT
- Index lesion size using the largest diameter [ Time Frame: Baseline ]Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176979
|Contact: Zeno Ashai, MPHfirstname.lastname@example.org|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Mary Yamashita 323-865-3203 email@example.com|
|Principal Investigator: Mary Yamashita|
|Principal Investigator:||Mary Yamashita, MD||University of Southern California|