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

Memorial Sloan Kettering Cancer Center0 sitesAugust 3, 2023

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Primary Endpoint: Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
Status: Withdrawn
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2023

End Date

July 26, 2024

Last Updated

11 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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 \<
•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

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.