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
Description
Brief Summary
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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion Criteria
- Newly diagnosed breast cancer patients
- Women with history of surgical, medical, or radiation therapy for breast cancer
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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