Breast DensityNCT01086241
Tomosynthesis in Screening Mammography
A study testing 2D Mammogram and Tomosynthesis in people with Breast Density, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women only
- Conditions the study is for
- Breast Density
- What is being tested?
- 2D Mammogram and Tomosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
- Prior mammogram report indicating ≥ 25% breast density.
Who cannot join
- Prior mammogram report indicating <25% breast density.
- Breast implants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
Read the detailed description
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.
- Conditions
- Breast Density
- Being tested
- 2D Mammogram, Tomosynthesis
- Keywords
- Tomography, Mammography, Breast Neoplasms, Prevention and Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D MammogramProcedure or surgery
Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
TomosynthesisProcedure or surgery
Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
| Study group | Role | What they receive |
|---|---|---|
| A: routine 2D mammogram | Active comparator | Subject receives regular 2D mammogram. Receives: Procedure: 2D Mammogram |
| B: Routine Mammogram + tomosynthesis | Active comparator | Routine Mammogram and tomosynthesis Receives: Procedure: Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpretation Time of Scan
Measured: Within 1 month of receiving scan
Secondary outcomes (2)
Recall Rates
Measured: 6 month intervals for 2 years after initial scan
Discomfort Scale
Measured: Immediately after the subject receives scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DensityStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- Aalo Bistritz, MD, Study chair, Cross Cancer InstituteAalo Bistritz, MD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086241
- Sponsor's protocol ID
- DX-TOM-001 25232
- Other IDs
- DX-TOM-001 25232
- Status last verified
- Jun 2025
- First submitted
- 11 Mar 2010
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography
- ClinicalTrials.gov ID
- NCT01086241
- Acronym / sponsor ID
- DX-TOM-001 25232
- Conditions
- Breast Density
- Keywords
- Tomography, Mammography, Breast Neoplasms, Prevention and Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- May 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Mar 2010 (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.
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
Detailed description
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: routine 2D mammogram | Active comparator | Procedure: 2D MammogramSubject receives regular 2D mammogram. |
| B: Routine Mammogram + tomosynthesis | Active comparator | Procedure: TomosynthesisRoutine Mammogram and tomosynthesis |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
- Prior mammogram report indicating ≥ 25% breast density.
Key exclusion criteria (3 listed)
- Prior mammogram report indicating <25% breast density.
- Breast implants
- Pregnancy
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 |
|---|---|---|
| 2D MammogramThose patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast. | Procedure or surgery | A: routine 2D mammogram |
| TomosynthesisThose patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast. | Procedure or surgery | B: Routine Mammogram + tomosynthesis |
Primary outcome
Interpretation Time of Scan
Time frame: Within 1 month of receiving scan
2 secondary outcomes
Recall Rates
Time frame: 6 month intervals for 2 years after initial scan
Discomfort Scale
Time frame: Immediately after the subject receives scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
Aalo Bistritz, MD study chair
Cross Cancer Institute
Aalo Bistritz, MD principal investigator
Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D Mammogram and Tomosynthesis in people with Breast Density, run by AHS Cancer Control Alberta at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interpretation Time of Scan (time frame: Within 1 month of receiving scan). 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 29 Jun 2025.