Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Breast Magnetic Resonance Imaging (MRI); Diagnostic Test: Contrast Enhanced Mammography (CEDM)

• Registration Number: NCT03070340
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-28
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Status Verified: 2023-11
• Primary Completion: 2023-11-17
• Study Completion: 2023-11-17
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast MRI and Contrast Enhanced Mammography (CEDM)	Breast Magnetic Resonance Imaging (MRI)	Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy
Breast MRI and Contrast Enhanced Mammography (CEDM)	Contrast Enhanced Mammography (CEDM)	Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy

Primary Outcome Measures

Name	Time	Method
Compare diagnostic accuracy of breast MRI and CEDM	1 year	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

Trial Locations

Locations (5)

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Consent only); 🇺🇸 Harrison, New York, United States