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Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

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ClinicalTrials.gov Identifier: NCT03070340
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Breast Magnetic Resonance Imaging (MRI) Diagnostic Test: Contrast Enhanced Mammography (CEDM) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Compare diagnostic accuracy of breast MRI and CEDM [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070340


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Janice Sung, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03070340    
Other Study ID Numbers: 17-045
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
mastectomy
breast MRI
contrast enhanced mammography
CEDM
17-045