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

Not Applicable

Completed

• Conditions: Breast Carcinoma
• Interventions: Other: Contrast Agent; Procedure: Digital Tomosynthesis Mammography; Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography

• Registration Number: NCT03176979
• Lead Sponsor: University of Southern California

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-21
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Newly diagnosed breast cancer patients

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CESM with DBT)	Dual-Energy Contrast-Enhanced Digital Spectral Mammography	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.
Diagnostic (CESM with DBT)	Digital Tomosynthesis Mammography	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.
Diagnostic (CESM with DBT)	Contrast Agent	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.

Primary Outcome Measures

Name	Time	Method
Index lesion size using the largest diameter	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States