Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Study Overview
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Brief Summary
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Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

Detailed Description
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Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.

Official Title
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A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: CE-BMRI
* Device: DE-CEDM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman 21 years of age or older The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained. Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days. Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis. Exclusion Criteria: Woman who has already had a lumpectomy for the index lesion. Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy. Woman who is pregnant or who believe she may be pregnant. Woman who has breast implant. Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CE-BMRI<br>Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. | Device: CE-BMRI<br>* Contrast-enhanced breast imaging using Magnetic Resonance<br>Device: DE-CEDM<br>* Breast imaging using Dual-energy, contrast-enhanced digital mammography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of CE-BMRI and DE-CEDM | Subjects have completed both CE-BMRI and DE-CEDM scan types | Approximately 8 weeks | 
| Average Maximum Lesion Size by CE-BMRI Scan | Average maximum lesion size when scanned using CE-BMRI | Within 1 week of CE-BMRI scan | 
| Average Maximum Lesion Size by DE-CEDM | Average maximum lesion size when scanned using DE-CEDM | Within 1 week of DE-CEDM scan | 
| Average Maximum Lesion Size by Histology Outcome | Average maximum lesion size as described in histology report. | Approximately 1 week; upon completion of histology report | 
| Multi-reader Evaluation of Images | Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study. | This outcome did not occur due to premature study stop. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mammography