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Screening CEDM in Intermediate and High-Risk Patient Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859492
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Bhavika Patel, Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Device: Contrast Enhanced Digital Mammography

Study Design
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Study Type : Observational
Actual Enrollment : 461 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Intermediate or high-risk breast cancer subjects
Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM)
 Device: Contrast Enhanced Digital Mammography
High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image
Other Name: CEDM


Outcome Measures
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Primary Outcome Measures :
  1. Breast Cancer [ Time Frame: 3 years ]
    Number of subjects diagnosed with breast cancer


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Potentially eligible patients who are scheduled for a mammogram will be prescreened based on their breast cancer risk level.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859492


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Bhavika Patel, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Bhavika Patel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03859492    
Other Study ID Numbers: 18-010602
NCI-2022-11058 ( Registry Identifier: NCI )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No