Study Stopped
Challenges to participant accrual
A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer
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
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2023
CompletedFirst Submitted
Initial submission to the registry
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2024
CompletedMay 21, 2025
May 1, 2025
12 months
August 4, 2023
May 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
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
Study Arms (1)
Participants with Breast Cancer
Participants will have a diagnosis of breast cancer
Interventions
Participants will have pre- and post-treatment CEM of the affected breast
Pre- and post-NAT breast MRI will be performed for all participants
Eligibility Criteria
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).
You may qualify if:
- Any women \>18 years of age at time of informed consent
- Diagnosed with breast cancer and schedule for NAT
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joao Machado Horvat, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2023
First Posted
August 14, 2023
Study Start
August 3, 2023
Primary Completion
July 26, 2024
Study Completion
July 26, 2024
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
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.