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

Memorial Sloan Kettering Cancer Center

Overview

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 Type

OBSERVATIONAL

Conditions

Breast Cancer

Interventions

Contrast-Enhanced MammographyDIAGNOSTIC_TEST

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

Breast MRIDIAGNOSTIC_TEST

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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