Breast Cancer Clinical Trial
Official title:
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
NCT number | NCT05990478 |
Other study ID # | 23-224 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 3, 2023 |
Est. completion date | August 3, 2027 |
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | August 3, 2027 |
Est. primary completion date | August 3, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering at Basking Ridge (All protocol activities) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (All protocol activities) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center (All protocol activites) | New York | New York |
United States | Memorial Sloan Kettering Nassau (All protocol activities) | Rockville Centre | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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