NCT03070340

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

6.7 years

First QC Date

February 28, 2017

Last Update Submit

November 17, 2023

Conditions

Breast Cancer

Keywords

mastectomybreast MRIcontrast enhanced mammographyCEDM17-045

Outcome Measures

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

    1 year

Study Arms (1)

Breast MRI and Contrast Enhanced Mammography (CEDM)

EXPERIMENTAL

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

Breast Magnetic Resonance Imaging (MRI)DIAGNOSTIC_TEST

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.

Breast MRI and Contrast Enhanced Mammography (CEDM)
Contrast Enhanced Mammography (CEDM)DIAGNOSTIC_TEST

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.

Breast MRI and Contrast Enhanced Mammography (CEDM)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janice Sung, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

February 28, 2017

Primary Completion

November 17, 2023

Study Completion

November 17, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

US(5)