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

Withdrawn

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Contrast-Enhanced Mammography; Diagnostic Test: Breast MRI

• Registration Number: NCT05990478
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-03
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Breast Cancer	Contrast-Enhanced Mammography	Participants will have a diagnosis of breast cancer
Participants with Breast Cancer	Breast MRI	Participants will have a diagnosis of breast cancer

Primary Outcome Measures

Name	Time	Method
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition	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.