Tomosynthesis Mammographic Imaging Screening Trial

NCT ID: NCT02616432

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3065 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Tomosynthesis + FFDM

Women enrolled to DBT Arm will undergo manufacturer-defined DBT

Group Type EXPERIMENTAL

Tomosynthesis

Intervention Type DEVICE

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

FFDM - Standard of Care for Screening

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tomosynthesis

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Cooperative Oncology Group

NETWORK

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Roberta Jong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberta A Jong, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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

Vancouver, British Columbia, Canada

Site Status

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

Vancouver, British Columbia, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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410000662

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

001-2014b

Identifier Type: -

Identifier Source: org_study_id

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