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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05990478
Collaborator
(none)
130
Enrollment
7
Locations
48
Anticipated Duration (Months)
18.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Contrast-Enhanced Mammography
  • Diagnostic Test: Breast MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
130 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Aug 3, 2023
Anticipated Primary Completion Date :
Aug 3, 2027
Anticipated Study Completion Date :
Aug 3, 2027

Arms and Interventions

Arm Intervention/Treatment
Participants with Breast Cancer

Participants will have a diagnosis of breast cancer

Diagnostic Test: Contrast-Enhanced Mammography
Participants will have pre- and post-treatment CEM of the affected breast
Other Names:
  • CEM

    • Diagnostic Test: Breast MRI
    Pre- and post-NAT breast MRI will be performed for all participants

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering at Basking Ridge (All protocol activities) Basking Ridge New Jersey United States 07920
    2 Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen (All protocol activities) Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) Commack New York United States 11725
    5 Memorial Sloan Kettering Westchester (All Protocol Activities) Harrison New York United States 10604
    6 Memorial Sloan Kettering Cancer Center (All protocol activites) New York New York United States 10065
    7 Memorial Sloan Kettering Nassau (All protocol activities) Rockville Centre New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Joao Machado Horvat, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05990478
    Other Study ID Numbers:
    • 23-224
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    breast cancer
    Memorial Sloan Kettering Cancer Center
    23-224
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 14, 2023