Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2023-11-17

Brief Summary

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The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT).

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breast MRI and Contrast Enhanced Mammography (CEDM)

Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy

Group Type EXPERIMENTAL

Breast Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.

Contrast Enhanced Mammography (CEDM)

Intervention Type DIAGNOSTIC_TEST

All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.

Interventions

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Breast Magnetic Resonance Imaging (MRI)

All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.

Intervention Type DIAGNOSTIC_TEST

Contrast Enhanced Mammography (CEDM)

All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
* Surgery (mastectomy or BCT) planned within 60 days of the MRI

Exclusion Criteria

* Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level \> 1.3 or eGFR ≥45)
* Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy
* Pregnant women
* Male patients
* Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
* Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice
* Women who have already had their standard of care post-NAT mammogram and/or breast MRI

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No