Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion

Study Overview
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Brief Summary
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This clinical trial investigates contrast-enhanced mammography (CEM) in detecting breast cancer. CEM is similar to standard mammography, but it includes an injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. Diagnostic procedures, such as CEM, may increase the chance of finding breast cancers and decrease the risk of having unnecessary biopsies.

Detailed Description
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PRIMARY OBJECTIVE: I. To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast. SECONDARY OBJECTIVES: I. To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast. II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth. III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis. EXPLORATORY OBJECTIVES: I. To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort. II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US. III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions. OUTLINE: Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed. After completion of study treatment, patients are followed up for 12 months.

Official Title
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Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center

Conditions
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Breast Carcinoma, Invasive Breast Carcinoma

Intervention / Treatment
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* Procedure: Contrast-Enhanced Mammography
* Procedure: Digital Tomosynthesis Mammography
* Other: Electronic Health Record Review
* Drug: Iodinated Contrast Agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC) Willingness to participate in the study and ability to provide informed consent Exclusion Criteria: Breast surgery within 6 months Known allergy to iodine-containing contrast agents History of anaphylactic reaction to any substance that required hospitalization or IV placement Renal insufficiency; hyperthyroidism Detection of non-breast primary or metastatic cancer in the breast

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CEM, DBT, medical record)<br>Patient receive iodinated contrast agent IV and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed. | Procedure: Contrast-Enhanced Mammography<br>* Undergo CEM<br>* Other names: CEM;Procedure: Digital Tomosynthesis Mammography<br>* Undergo DBT<br>* Other names: Digital Tomosynthesis of the Breast;Other: Electronic Health Record Review<br>* Medical records reviewed<br>Drug: Iodinated Contrast Agent<br>* Given IV<br>* Other names: Iodine-containing Contrast Media;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of contrast enhanced mammography (CEM) for incremental cancer detection in the ipsilateral and contralateral breasts | Defined as the number of concordant cases between CEM/low energy (LE) and pathologic evaluation divided by the total sample size. Will be estimated along with 95% confidence intervals; and compared between the modalities using the McNemar test or the weighted generalized score statistic proposed by Kosinski, if deemed appropriate. To account for multiple lesions, outcome variables will be analyzed using generalized liner mix models or extended McNemar's test, and additional analyses may be further performed if deemed appropriate. | Up to 12 months |