Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)
Condition: Breast Cancer
Intervention: Digital Mammography; Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml
Intervention description: Digital Mammography enhanced with an iodinated contrast agent; Injection of low osmolar contrast material during the digital mammography exam
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mammography; contrast enhanced spectral mammography

Summary:

      This study is designed to investigate the diagnostic accuracy of Contrast Enhanced Spectral
      Mammography (CEDM) in predicting early neoadjuvant therapy response and pathologic complete
      response (pCR) compared to mammography.

      Patients diagnosed with invasive breast cancer with available mammography and ultrasound
      imaging are eligible for the study.

      Eligible patients will be imaged at baseline (before initiation of neoadjuvant chemotherapy
      or endocrine therapy), early (2-4 cycles of neoadjuvant therapy) and late (after completion
      of neoadjuvant chemotherapy or endocrine therapy) timepoints with mammography. CEDM will be
      done within 2 weeks of the specified timepoint. Additionally, a survey of subject experience
      with CEDM and other pre-operative imaging will be collected after CEDM is performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ipsilateral intact biopsy-proven breast cancer clinical stage T1-T4 (by imaging)

          -  Available mammography and ultrasound imaging of the existing index cancer, with
             orthogonal measurements

          -  Prior history of ipsilateral or contralateral breast cancer, presenting with a new
             primary or recurrent disease

          -  Patients who were determined to be candidates for either neoadjuvant chemotherapy or
             neoadjuvant endocrine therapy by the treating physician

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and for days following completion of study
             participation. Should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately.

        Exclusion Criteria:

          -  History of ipsilateral mastectomy

          -  Women who already started neoadjuvant chemotherapy or endocrine therapy

          -  Woman who may be pregnant or nursing an infant

          -  Prior history of anaphylactic or anaphylactoid reaction to any contrast.

          -  Prior allergy to iodine or iodinated contrast.

          -  Impaired renal function measured by estimated glomerular filtration rate (eGFR) < 60
             milliliters per minute.

          -  Patients with known distant metastasis.