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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05990478

Enrollment

Registered

2023-08-14

Start date

2023-08-03

Completion date

2024-07-26

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, Memorial Sloan Kettering Cancer Center, 23-224

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.

Interventions

DIAGNOSTIC_TESTContrast-Enhanced Mammography

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

DIAGNOSTIC_TESTBreast MRI

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026