NCT02616432

Brief Summary

A randomized screening trial to compare the diagnostic accuracy of screening for breast cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional full-field digital mammography (FFDM) versus FFDM alone.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
3,065

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
19mo left

Started Oct 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

4 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 Progress88%
Oct 2014Dec 2027

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 27, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

13.2 years

First QC Date

November 10, 2015

Last Update Submit

May 16, 2025

Conditions

Breast Cancer

Keywords

TomosynthesisDigital Breast Tomosynthesis (DBT)Breast ImagingFull-field digital mammographyBreast screening

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison

    To compare the diagnostic accuracy using the area under the curve (AUC) score generated by receiver operator characteristic (ROC) analysis of digital breast tomosynthesis plus full-field digital mammography (DBT) versus full-field digital mammography (FFDM) alone for breast cancer screening. The examinations will be interpreted by local Breast Imaging radiologists. Cancer status will be pathologically confirmed. The women would undergo three consecutive screening rounds in the assigned arm followed by one year of standard of care imaging follow-up.

    3 year follow-up

Secondary Outcomes (6)

  • Recall Rates

    3 year

  • Interval Cancers

    3 year

  • Prevalence of Breast Cancer Subtypes

    3 year

  • Clinical Characteristics of Cancers

    3 year

  • Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison

    4 year

  • +1 more secondary outcomes

Study Arms (2)

Tomosynthesis + FFDM

EXPERIMENTAL

Women enrolled to DBT Arm will undergo manufacturer-defined DBT

Device: Tomosynthesis

FFDM - Standard of Care for Screening

NO INTERVENTION

Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired

Interventions

TomosynthesisDEVICE

Three-dimensional imaging of both breasts in standard CC and MLO views

Tomosynthesis + FFDM

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic women age 40 and over
  • Scheduled for screening mammogram
  • Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol
  • Willing and able to provide a written informed consent.

You may not qualify if:

  • Presenting for mammography with symptoms of breast disease
  • Have new breast complaints (e.g. lump, nipple discharge)
  • Have had a mammogram of both breasts within the last 11 months
  • Previous personal history of breast cancer
  • Has breast enhancements (e.g. implants or injections)
  • Pregnancy or intent to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

X-Ray 505 (Under the BCCA Screening Mammography Program of BC)

Vancouver, British Columbia, V5Z 1H4, Canada

Location

Breast Health Centre at BC Women's Hospital + Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Roberta A Jong, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 27, 2015

Study Start

October 1, 2014

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
Immediate
Access Criteria
ECOG/ACRIN Sharing Access policy

Locations

CA(4)