Clinical trial NCT02616432: Tomosynthesis Mammographic Imaging Screening Trial
Official title: Tomosynthesis Mammography Imaging Screening Trial Lead-in
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Tomosynthesis
Digital Breast Tomosynthesis (DBT)
Breast Imaging
Full-field digital mammography
Breast screening
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Eastern Cooperative Oncology Group
First posted: 2015-11-27
Enrollment: 3065
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: The Tomosynthesis Mammography Imaging Screening Trial (TMIST) LEAD-IN is being conducted to ensure that all Eastern Cooperative Oncology Group / American College of Radiology Imaging Network (ECOG/ACRIN) TMIST components are properly functional and to provide an opportunity for fine tuning before launching the full TMIST. The accrual target for TMIST LEAD-IN is 6354 participants (one tenth of the projected enrollment target for TMIST) at three lead-in study sites: 1. Sunnybrook Health Sciences Centre in Toronto, 2. Vancouver (under the auspices of the Screening Mammography Programme of British Columbia) and 3. The Ottawa Hospital.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
timeFrame: 3 year follow-up
Secondary outcomes:
measure: Recall Rates
timeFrame: 3 year
measure: Interval Cancers
timeFrame: 3 year
measure: Prevalence of Breast Cancer Subtypes
timeFrame: 3 year
measure: Clinical Characteristics of Cancers
timeFrame: 3 year
measure: Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison
timeFrame: 4 year
measure: Biomarker Correlation
timeFrame: 2 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: X-Ray 505 (Under the BCCA Screening Mammography Program of BC)
state: British Columbia
city: Vancouver
country: Canada
facility: Breast Health Centre at BC Women's Hospital + Health Centre
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Roberta A Jong, MD
role: PRINCIPAL_INVESTIGATOR
References: