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Challenges to participant accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Breast Cancer | Participants will have a diagnosis of breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-Enhanced Mammography | Diagnostic Test | Participants will have pre- and post-treatment CEM of the affected breast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Potential research subjects will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).
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| Name | Affiliation | Role |
|---|---|---|
| Joao Machado Horvat, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Breast MRI | Diagnostic Test | Pre- and post-NAT breast MRI will be performed for all participants |
|
| D017437 |
| Skin and Connective Tissue Diseases |