Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Breast Magnetic Resonance Imaging (MRI); Diagnostic test: Contrast Enhanced Mammography (CEDM)

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Consent Only)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent Only)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Consent Only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent Only)
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Breast MRI and Contrast Enhanced Mammography (CEDM); Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy

Diagnostic test: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare diagnostic accuracy of breast MRI and CEDM	To compare the diagnostic accuracy of enhancement on MRI and CEDM in evaluating residual disease extent in women who have completed NAT prior to surgical excision	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Janice Sung, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: mastectomy; breast MRI; contrast enhanced mammography; CEDM; 17-045
• Other Study ID Numbers: 17-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No