Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

University of Southern California

Status: Completed

Conditions: Breast Carcinoma

Treatments: Procedure: Digital Tomosynthesis Mammography; Other: Contrast Agent; Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03176979

NCI-2017-00778 (Registry Identifier)

1B-16-3 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed breast cancer patients

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Diagnostic (CESM with DBT)

Experimental group

Description:

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.

Treatment:

Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography

Other: Contrast Agent

Procedure: Digital Tomosynthesis Mammography