Breast NeoplasmsEarly Phase 1NCT00722059
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
A Early Phase 1 study testing Breast Tomosynthesis in people with Breast Neoplasms and Breast Abnormalities, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Abnormalities
- What is being tested?
- Breast Tomosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Oct 2013
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 30 years of age or older.
- Dense Breasts.
- Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
- Suspicious or palpable mass and scheduled for biopsy.
Who cannot join
- Pregnant or lactating women.
- Prior personal history of breast cancer.
- Prior breast augmentation with implants or silicon injection. male patients.
- No two view mammogram as part of breast imaging evaluation.
- Breast density of almost entirely fatty/scattered fibroglandular densities.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
- Conditions
- Breast Neoplasms, Breast Abnormalities
- Being tested
- Breast Tomosynthesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast TomosynthesisProcedure or surgery
3D breast imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes. Receives: Procedure: Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of digital tomosynthesis and digital mammography test performance.
Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis V. Nees M.D., University of Michigan
- Investigators
- Alexis V. Nees, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722059
- Sponsor's protocol ID
- HUM 13236
- Status last verified
- Jan 2014
- First submitted
- 23 Jul 2008
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
- ClinicalTrials.gov ID
- NCT00722059
- Acronym / sponsor ID
- HUM 13236
- Conditions
- Breast Neoplasms, Breast Abnormalities
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Jul 2008 (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 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Breast TomosynthesisSubjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females 30 years of age or older.
- Dense Breasts.
- Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
- Suspicious or palpable mass and scheduled for biopsy.
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Prior personal history of breast cancer.
- Prior breast augmentation with implants or silicon injection. male patients.
- No two view mammogram as part of breast imaging evaluation.
- Breast density of almost entirely fatty/scattered fibroglandular densities.
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 |
|---|---|---|
| Breast Tomosynthesis3D breast imaging | Procedure or surgery | 1 |
Primary outcome
Measure of digital tomosynthesis and digital mammography test performance.
Time frame: 3 weeks
Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.
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 3 Feb 2014.
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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.
Alexis V. Nees, M.D. principal investigator
University of Michigan
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 Breast Tomosynthesis in people with Breast Neoplasms and Breast Abnormalities, run by University of Michigan 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 5 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 3 Feb 2014. 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?
Measure of digital tomosynthesis and digital mammography test performance. (time frame: 3 weeks). 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 3 Feb 2014.