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Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE February 28, 2017
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 28, 2017)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070340
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janice Sung, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP