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OpenTrials
Completed

NCT Number: NCT03859492

Screening CEDM in Intermediate and High-Risk Patient Populations

This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.

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Key information

Conditions

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

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 35 and 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
  • 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

Treatment and study plan

Contrast Enhanced Digital Mammography

Device

High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image

Other names: CEDM

Primary outcomes

  1. Breast Cancer

    Time frame: 3 years

    Number of subjects diagnosed with breast cancer

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2019
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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