Contrast-Enhanced Mammography (CEM) and CEM-Directed Biopsy for the Evaluation of Extensive Suspicious Mammographic Microcalcifications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Accuracy
Study Overview
Brief Summary
This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the added value of contrast enhancement of CEM compared to two dimensional (2D) mammography in predicting invasive malignancy or high-grade DCIS in patients with suspicious mammographic microcalcifications.
SECONDARY OBJECTIVES:
I. To evaluate the added value of contrast enhancement in CEM by comparing the sensitivity/specificity of contrast enhancement to the sensitivity/specificity of FFDM.
II. To evaluate whether the absence of contrast enhancement can predict the absence of high grade DCIS or invasive cancer by establishing the negative predictive value (NPV) of contrast enhancement and comparing it to the NPV of FFDM.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 25 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with suspicious mammographic microcalcifications (Breast Imaging Reporting and Data System [BI-RADS] categories 4 or 5) occupying an area equal to or exceeding 4 cm in diameter and recommended for a stereotactic biopsy, who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their stereotactic biopsy at MDACC.
- •Age 25-85 years
- •Willing to participate in the study, undergo an intravenous (IV) placement, able to undergo iodinated contrast injection, and able to provide informed consent
Exclusion Criteria
- •Reported history of an allergic reaction to iodinated contrast
- •History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
- •Renal insufficiency
- •Pregnancy or lactation within 6 months
- •Breast surgery affecting the site of interest within prior 6 months
- •Breast biopsy at the site of interest within the last 2 months
- •Mammographic mass or architectural distortion associated with the calcifications in question
Arms & Interventions
Diagnostic (contrast-enhanced mammography)
Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM.
Intervention: Questionnaire Administration (Other)
Diagnostic (contrast-enhanced mammography)
Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM.
Intervention: Biospecimen Collection (Procedure)
Diagnostic (contrast-enhanced mammography)
Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM.
Intervention: Contrast Agent (Other)
Diagnostic (contrast-enhanced mammography)
Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM.
Intervention: Contrast-Enhanced Mammography (Procedure)
Outcomes
Primary Outcomes
Accuracy
Time Frame: Up to 1 year
Determined by comparing the contrast-enhanced mammography (CEM)/full field digital mammography (FFDM) results to those of the pathologic evaluations. Specifically, it is defined as the number of concordant cases between CEM/FFDM and pathologic evaluation divided by the total sample size. Descriptive statistics will be used to summarize clinical variables of interest. Specifically, categorical measures will be summarized using frequencies and percentages, and continuous measures will be summarized using means, standard deviations, medians, and ranges.
Secondary Outcomes
No secondary outcomes reported