A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer

NCT ID: NCT05990478

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-03

Study Completion Date

2024-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Breast Cancer

Participants will have a diagnosis of breast cancer

Contrast-Enhanced Mammography

Intervention Type DIAGNOSTIC_TEST

Participants will have pre- and post-treatment CEM of the affected breast

Breast MRI

Intervention Type DIAGNOSTIC_TEST

Pre- and post-NAT breast MRI will be performed for all participants

Interventions

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Contrast-Enhanced Mammography

Participants will have pre- and post-treatment CEM of the affected breast

Intervention Type DIAGNOSTIC_TEST

Breast MRI

Pre- and post-NAT breast MRI will be performed for all participants

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CEM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joao Machado Horvat, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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23-224

Identifier Type: -

Identifier Source: org_study_id

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