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CompletedNCT03070340Updated Nov 21, 2023

Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

An interventional study of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 5 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2023-11-21.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Sex
Female
01

Study summary

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).

02

Conditions studied

  • Breast Cancer

Keywords

  • mastectomy
  • breast MRI
  • contrast enhanced mammography
  • CEDM
  • 17-045
03

In context

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • 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) · Diagnostic Test: Contrast Enhanced Mammography (CEDM)

Interventions

  • Diagnostic testBreast 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 testContrast 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

5 sites
  • Memorial Sloan Kettering Basking Ridge (Consent only)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Bergen (Consent only)
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Commack (Consent only)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (Consent only)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
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References and documents

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03070340
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Mar 3, 2017
Start date
Feb 28, 2017
Primary completion
Nov 17, 2023
Completion
Nov 17, 2023
Last update
Nov 21, 2023

Study contacts

Janice Sung, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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