Screening CEDM in Intermediate and High-Risk Patient Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2021-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients are prospectively assigned to the CEDM /screening intervention which may lead to additional screening or biopsy based on the study schema.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Contrast Enhanced Digital Mammography

Intervention Type DEVICE

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

Interventions

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Contrast Enhanced Digital Mammography

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

Intervention Type DEVICE

Other Intervention Names

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CEDM

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes