NCT04085510

Brief Summary

This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,647

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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 Progress71%
Oct 2019Dec 2028

First Submitted

Initial submission to the registry

September 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

7.9 years

First QC Date

September 6, 2019

Last Update Submit

March 5, 2026

Conditions

Breast Cancer FemaleBreast CancerBreast NeoplasmsNeoplasms

Keywords

breast cancer screeningdigital breast tomosynthesiscontrast-enhanced mammogram

Outcome Measures

Primary Outcomes (1)

  • Cancer Detection

    Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens.

    48 months

Secondary Outcomes (1)

  • Reader Validation

    48 months

Study Arms (1)

Contrast-enhanced mammogram

EXPERIMENTAL

All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists

Device: Contrast-enhanced mammogram

Interventions

Contrast-enhanced mammogramDEVICE

Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.

Contrast-enhanced mammogram

Eligibility Criteria

Age30 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

You may not qualify if:

  • Women with a history of prior iodinated contrast reaction
  • Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
  • Women who have had bilateral mastectomy
  • Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) \< 30 mL/min
  • Pregnancy or lactation
  • Women actively being treated for cancer of any type with chemotherapy
  • Lump or other breast symptoms
  • Abnormality on prior breast imaging that is being followed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Magee Womancare Passavant Cranberry

Cranberry Township, Pennsylvania, 16066, United States

Location

Magee Womancare Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wendie Berg, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 11, 2019

Study Start

October 23, 2019

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Images may be shared with secondary investigators, including commercial companies after removal of all identifiers. All participant identification (name, patient number, birth date) will be removed prior to sharing.

Shared Documents
STUDY PROTOCOL
Time Frame
At study conclusion
Access Criteria
Participant imaging may be shared with secondary investigators, including commercial companies either by electronic transfers or via disc downloads. All participant identification will be removed prior to the images release.

Locations

US(3)