NCT03859492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

February 28, 2019

Last Update Submit

August 22, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer

    Number of subjects diagnosed with breast cancer

    3 years

Study Arms (1)

Intermediate or high-risk breast cancer subjects

EXPERIMENTAL

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

Interventions

Contrast Enhanced Digital MammographyDEVICE

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

Also known as: CEDM
Intermediate or high-risk breast cancer subjects

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bhavika Patel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Patients are prospectively assigned to the CEDM /screening intervention which may lead to additional screening or biopsy based on the study schema.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 1, 2019

Study Start

February 15, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

US(1)