Tomosynthesis Mammographic Imaging Screening Trial (TMISTLead-in)

Sunnybrook Health Sciences Centre

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Device: Tomosynthesis

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02616432

410000662 (Other Grant/Funding Number)

001-2014b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,065 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,065 participants in 2 patient groups

Tomosynthesis + FFDM

Experimental group

Description:

Women enrolled to DBT Arm will undergo manufacturer-defined DBT

Treatment:

Device: Tomosynthesis

FFDM - Standard of Care for Screening

No Intervention group

Description:

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