Fibrocystic Disease of BreastEarly Phase 1NCT00826488
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
A Early Phase 1 study testing Digital Breast Tomosynthesis in people with Fibrocystic Disease of Breast and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women only
- Conditions the study is for
- Fibrocystic Disease of Breast, Breast Cancer
- What is being tested?
- Digital Breast Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2014
- Phase
- Early Phase 1
- 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 35 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Any race or ethnicity
- At least 35 years old
- Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center
Who cannot join
- Unable or unwilling to undergo informed consent
- Subjects who have breast implants
- Subjects who are unable or unwilling to tolerate compression
- Subjects who are pregnant or who think they may be pregnant
- Subjects who are currently lactating
- Men
Show all 9Show fewer
- Women less than 35 years old
- Women greater than 80 years old
- Subjects whose breasts are larger than the tomosynthesis detector
Trial locations and contacts
1 site in 1 country.
United States1 site
JoAnne Knight Breast Center, Barnes Hospital
St Louis, Missouri, 63110
About this study
Official title: A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
- Conditions
- Fibrocystic Disease of Breast, Breast Cancer
- Being tested
- Digital Breast Tomosynthesis
- Keywords
- Breast Cancer, Mammography, Benign masses, Breast Lump, Breast Biopsy, Breast Mass
- Medical subject headings
- Fibrocystic Breast Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast TomosynthesisDevice
Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.
| Study group | Role | What they receive |
|---|---|---|
| observational | Other | Observational Receives: Device: Digital Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrocystic Disease of BreastStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darlene Bird, R.T. (M), Washington University School of Medicine
- Investigators
- Dione Farria, MD MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826488
- Sponsor's protocol ID
- DBT11212008
- Status last verified
- Jun 2015
- First submitted
- 20 Jan 2009
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
- ClinicalTrials.gov ID
- NCT00826488
- Acronym / sponsor ID
- DBT11212008
- Conditions
- Fibrocystic Disease of Breast, Breast Cancer
- Keywords
- Breast Cancer, Mammography, Benign masses, Breast Lump, Breast Biopsy, Breast Mass
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jan 2009 (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.
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational | Other | Device: Digital Breast TomosynthesisObservational |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Any race or ethnicity
- At least 35 years old
- Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center
Key exclusion criteria (9 listed)
- Unable or unwilling to undergo informed consent
- Subjects who have breast implants
- Subjects who are unable or unwilling to tolerate compression
- Subjects who are pregnant or who think they may be pregnant
- Subjects who are currently lactating
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 |
|---|---|---|
| Digital Breast TomosynthesisWomen with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram. | Device | observational |
Primary outcome
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
Time frame: 9 months
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 2 Jun 2015.
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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.
Dione Farria, MD MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Digital Breast Tomosynthesis in people with Fibrocystic Disease of Breast and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
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 9 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 2 Jun 2015. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup. (time frame: 9 months). 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 2 Jun 2015.