Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications

NCT05046301 | Active Not Recruiting

• 2 other identifiers: 2020-0501NCI-2021-08428
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Accuracy

  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.

  Up to 1 year

Study Arms (1)

Diagnostic (contrast-enhanced mammography)

Patients complete a questionnaire and undergo collection of a blood sample. Patients undergo CEM.

Procedure: Biospecimen Collection; Other: Contrast Agent; Procedure: Contrast-Enhanced Mammography; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Correlative studies

Also known as: Biological Sample Collection

Diagnostic (contrast-enhanced mammography)

Contrast Agent OTHER

Given IV

Also known as: Contrast, Contrast Drugs, contrast material, Contrast Medium

Diagnostic (contrast-enhanced mammography)

Contrast-Enhanced Mammography PROCEDURE

Undergo contrast-enhanced mammography

Also known as: CEM

Diagnostic (contrast-enhanced mammography)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (contrast-enhanced mammography)

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspicious mammographic microcalcifications

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Olena Weaver

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 16, 2021
• Study Start: March 23, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)