Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

• ClinicalTrials.gov Identifier: NCT03070340
• Recruitment Status: Active, not recruiting
• First Posted: March 3, 2017
• Last Update Posted: March 17, 2021
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: February 28, 2017
• First Posted Date: March 3, 2017
• Last Update Posted Date: March 17, 2021
• Actual Study Start Date: February 28, 2017
• Estimated Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2017)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery
• Official Title: Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Breast Cancer

Intervention

• 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.

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

Interventions:

• Diagnostic Test: Breast Magnetic Resonance Imaging (MRI)
• Diagnostic Test: Contrast Enhanced Mammography (CEDM)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 28, 2017): 125
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2022
• Estimated Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03070340
• Other Study ID Numbers: 17-045
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Memorial Sloan Kettering Cancer Center
• Study Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: March 2021