Breast CancerTMISTLead-inNCT02616432
Tomosynthesis Mammographic Imaging Screening Trial
A study testing Tomosynthesis in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,065 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2014to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Canada4 sites
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
X-Ray 505 (Under the BCCA Screening Mammography Program of BC)
Vancouver, British Columbia, V5Z 1H4
Breast Health Centre at BC Women's Hospital + Health Centre
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Tomosynthesis Mammography Imaging Screening Trial Lead-in
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Tomosynthesis
- Keywords
- Tomosynthesis, Digital Breast Tomosynthesis (DBT), Breast Imaging, Full-field digital mammography, Breast screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomosynthesisDevice
Three-dimensional imaging of both breasts in standard CC and MLO views
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis + FFDM | Experimental | Women enrolled to DBT Arm will undergo manufacturer-defined DBT Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 year follow-up
Secondary outcomes (6)
Recall Rates
To compare the recall rates due to abnormal screening examinations for DBT versus FFDM when used for breast cancer screening.
Measured: 3 year
Interval Cancers
To compare the number of interval cancers missed with DBT versus FFDM use in breast cancer screening.
Measured: 3 year
Prevalence of Breast Cancer Subtypes
To estimate the prevalence of breast cancer subtypes (Luminal A, Luminal B, HER2neu, Basal-like, Claudin-low) by DBT and FFDM, stratified on whether cancers were detected in screening or as interval cancers.
Measured: 3 year
Clinical Characteristics of Cancers
To assess and compare clinical characteristics (e.g. stage, grade, ER, PR, and HER2status) of cancers detected from screening by DBT and FFDM. Approximately 75 genes will be assayed in tumors detected in each arm of the study to evaluate breast cancer molecular subtype.
Measured: 3 year
Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison
To assess different combinations of FFDM, tomosynthesis and synthesized FFDM images in reader studies to assist in determining the optimum balance between radiation exposure and technique. AUC of ROC curves will be used to compare combinations. A panel of radiologists will read the various combinations of images in random order to assess whether tomosynthesis with synthetic 2D images is as accurate as tomosynthesis with FFDM images. The latter will require more radiation exposure.
Measured: 4 year
Biomarker Correlation
Biomarker correlation to characterize disease in the tumor and compare to the tissue immediately adjacent to it.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Cooperative Oncology Group
- Responsible party
- Principal investigator, Dr. Roberta Jong, Sunnybrook Health Sciences Centre
- Investigators
- Roberta A Jong, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616432
- Sponsor's protocol ID
- 001-2014b
- Other IDs
- 410000662
- Acronym
- TMISTLead-in
- Status last verified
- May 2025
- First submitted
- 10 Nov 2015
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomosynthesis Mammography Imaging Screening Trial Lead-in
- ClinicalTrials.gov ID
- NCT02616432
- Acronym / sponsor ID
- TMISTLead-in / 001-2014b
- Conditions
- Breast Cancer
- Keywords
- Tomosynthesis, Digital Breast Tomosynthesis (DBT), Breast Imaging, Full-field digital mammography, Breast screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,065 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Eastern Cooperative Oncology Group
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis + FFDM | Experimental | Device: TomosynthesisWomen enrolled to DBT Arm will undergo manufacturer-defined DBT |
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TomosynthesisThree-dimensional imaging of both breasts in standard CC and MLO views | Device | Tomosynthesis + FFDM |
Primary outcome
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
Time frame: 3 year follow-up
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.
6 secondary outcomes
Recall Rates
Time frame: 3 year
Interval Cancers
Time frame: 3 year
Prevalence of Breast Cancer Subtypes
Time frame: 3 year
Clinical Characteristics of Cancers
Time frame: 3 year
Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison
Time frame: 4 year
Biomarker Correlation
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. ECOG/ACRIN TMIST will collect all data when accrual starts for that trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta A Jong, MD principal investigator
Sunnybrook Health Sciences Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomosynthesis in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison (time frame: 3 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.