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Screening CEDM in Intermediate and High-Risk Patient Populations

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ClinicalTrials.gov Identifier: NCT03859492
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bhavika Patel, Mayo Clinic

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

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Study Type : Observational
Estimated Enrollment : 500 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
Estimated Primary Completion Date : February 17, 2021
Estimated Study Completion Date : February 17, 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

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 Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Nancy L Lizzul, R.N.    480-342-1335    Lizzul.Annunziata@mayo.edu   
Contact: Brandee L. Colter    480-342-3988    Colter.Brandee@mayo.edu   
Principal Investigator: Patel Bhavika, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Bhavika Patel, MD Mayo Clinic

Additional Information:
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Responsible Party: Bhavika Patel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03859492     History of Changes
Other Study ID Numbers: 18-010602
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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