A Study of Screening Contrast-Enhanced Digital Mammography (CEDM) in Intermediate and High-Risk Patient Populations

Overview

About this study

The primary purpose of this study is to evaluate the incremental invasive cancer yield in patients with a negative mammogram who are intermediate or high-risk for breast cancer and get supplemental screening with Contrast-Enhanced Digital Mammography (CEDM).

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Women aged 35 years and older.
  • Women who had a negative routine mammogram within 6 months.
  • Qualifies as intermediate or high-risk (> 15% lifetime risk of breast cancer as defined by IBIS version 8).

Exclusion Criteria:

  • Known breast cancer at time of study or within 12 months of enrollment.
  • Previously had negative MBI or MRI within 12 months of study.
  • Pregnant or lactating.
  • Contraindication to intravenous iodinated contrast.
  • Unable to understand or sign informed consent. 
  • Self-reported signs or symptoms of breast cancer. 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bhavika Patel, M.D.

Open for enrollment

Contact information:

Megan Kelly M.H.A.

(480) 342-1248

Kelly.Megan1@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20491414

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