NCT03517813

Brief Summary

This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy. Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3). Secondary Aims:

  1. 1.Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities.
  2. 2.Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

January 3, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

March 27, 2018

Last Update Submit

January 4, 2023

Conditions

Breast Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • Abnormal interpretation rate

    Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)

    2 years

Secondary Outcomes (6)

  • Biopsy rate

    2 years

  • Positive predictive value for biopsy recommendation (PPV2)

    3 years

  • Negative predictive value

    3 years

  • Cancer detection rate

    3 years

  • Sensitivity

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Cohort 1

Asymptomatic women at increased risk of breast cancer referred clinically for high risk screening breast MRI or women with newly diagnosed primary unilateral breast cancer referred for evaluation of extent of disease (EOD) in the index breast and screening of the contralateral breast. All women enrolled on study will complete a clinical breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam.

Device: Contrast-enhanced Spectral Mammography (CESM)

Cohort 2

Women receiving MRI for any indication and for whom percutaneous biopsy with ultrasound or MRI guidance has been recommended. All women enrolled on study will complete a standard breast MRI and research contrast enhanced mammogram. Abbreviated MRI images will be extracted from the standard breast MRI exam.

Device: Contrast-enhanced Spectral Mammography (CESM)

Interventions

Contrast-enhanced Spectral Mammography (CESM)DEVICE

Dual energy mammography images obtained after the administration of an intravenous contrast agent

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women referred for a clinical breast MRI.

You may qualify if:

  • Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
  • Women aged ≥18 years at the time of enrollment
  • Referred clinically for breast MRI for any indication

You may not qualify if:

  • Known allergy or contraindication to iodinated contrast
  • Are currently pregnant based on urine pregnancy test
  • Have breast implants
  • Are lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Cancer Care Alliance

Seattle, Washington, 98102, United States

Location

Study Officials

  • Janie M Lee

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

May 7, 2018

Study Start

January 3, 2018

Primary Completion

June 22, 2021

Study Completion

December 31, 2022

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)