Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications

Overseen By Ada Lo

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Allergy to iodine, Renal insufficiency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

151 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Olena Weaver

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients complete a questionnaire, undergo collection of a blood sample, and receive contrast intravenously for contrast-enhanced mammography (CEM).

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

24 months

Treatment Details

Interventions

• Biospecimen Collection
• Contrast Agent
• Contrast-Enhanced Mammography

Participant Groups

Group I: Diagnostic (contrast-enhanced mammography) Experimental Treatment 4 Interventions

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

Contrast-Enhanced Mammography is already approved in European Union, United States, China for the following indications:

Approved in European Union as CEM for:

• Breast cancer detection
• Preoperative staging
• Neoadjuvant chemotherapy response assessment

Approved in United States as CEM for:

• Breast cancer detection
• Supplemental screening in dense breasts

Approved in China as CEM for:

• Breast cancer detection
• Preoperative staging

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+