A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer
May 16, 2025 updated by: Memorial Sloan Kettering Cancer Center
Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer
The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (All Protocol Activities)
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (All Protocol Activities)
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All protocol activites)
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
Rockville Centre, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (All Protocol Activities)
-
Contact:
- Joao Machado Horvat, MD
- Phone Number: 646-888-5462
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Potential research subjects will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
Description
Inclusion Criteria:
- Any women >18 years of age at time of informed consent
- Diagnosed with breast cancer and schedule for NAT
Exclusion Criteria:
- History of kidney disease, creatinine level >1.3 or eGFR <45.
- Known allergic reaction to gadolinium or iodinated contrast media.
- Contraindication to contrast-enhanced breast MRI.
- Lesion not included in the field of view of either pre- or post-NAT MRI or CEM
- Presence of pacemakers or automated implantable cardioverter defibrilator
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer
|
Participants will have pre- and post-treatment CEM of the affected breast
Other Names:
Pre- and post-NAT breast MRI will be performed for all participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
Time Frame: Up to 1 year
|
compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joao Machado Horvat, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2023
Primary Completion (Actual)
July 26, 2024
Study Completion (Actual)
July 26, 2024
Study Registration Dates
First Submitted
August 4, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 16, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.