A Study of Screening Contrast-Enhanced Digital Mammography (CEDM) in Intermediate and High-Risk Patient Populations
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 18-010602
NCT ID: NCT03859492
Sponsor Protocol Number: 18-010602
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. |
Closed for enrollment |
Contact information:
Clinical Studies Unit
(904) 953-2255
|
More information
Publications
Publications are currently not available