Breast NeoplasmsNCT00637598
Early Detection of Breast Cancer Using Tomosynthesis Imaging
A study testing Mammography and tomosynthesis imaging in people with Breast Neoplasms, run by Duke University at 1 site in United States.
Trial summary
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Mammography and tomosynthesis imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Oct 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All Subjects accepted for this clinical study must:
- Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
- Provide written informed consent
- Be able to communicate effectively with clinical study personnel.
Who cannot join
- Subjects with any of the following conditions will be excluded from this clinical study:
- Childbearing potential and subject refuses serum pregnancy test or test result is positive.
Trial locations and contacts
1 site in 1 country.
United States1 site
DUMC Mammography, Duke South Hospital, 2nd floor
Durham, North Carolina, 27710
About this study
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.
Read the detailed description
Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.
- Conditions
- Breast Neoplasms
- Being tested
- Mammography and tomosynthesis imaging
- Keywords
- Diagnostic Imaging, Mammography, 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.
Mammography and tomosynthesis imagingRadiation
Also called Digital breast tomosynthesis (DBT), Breast tomosynthesis, full field digital mammography (FFDM), screen-film mammography
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis scans | Experimental | This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging. Receives: Radiation: Mammography and tomosynthesis imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
Measured: at imaging review by the end of the study, approximately 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startNov 2004
- Primary completionSep 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 Duke UniversityThe 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
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Y Lo, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637598
- Sponsor's protocol ID
- Pro00013552
- Other IDs
- 6024, 6503
- Status last verified
- Jul 2014
- First submitted
- 12 Mar 2008
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Breast Cancer Using Tomosynthesis Imaging
- ClinicalTrials.gov ID
- NCT00637598
- Acronym / sponsor ID
- Pro00013552
- Conditions
- Breast Neoplasms
- Keywords
- Diagnostic Imaging, Mammography, Breast Tomosynthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Mar 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 is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.
Detailed description
Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis scans | Experimental | Radiation: Mammography and tomosynthesis imagingThis is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
- Provide written informed consent
- Be able to communicate effectively with clinical study personnel.
Key exclusion criteria (2 listed)
- Childbearing potential and subject refuses serum pregnancy test or test result is positive.
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 |
|---|---|---|
| Mammography and tomosynthesis imagingAlso: Digital breast tomosynthesis (DBT), Breast tomosynthesis, full field digital mammography (FFDM), screen-film mammographyAll subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography). | Radiation | Tomosynthesis scans |
Primary outcome
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
Time frame: at imaging review by the end of the study, approximately 9 years
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 13 Apr 2017.
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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.
Joseph Y Lo, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography and tomosynthesis imaging in people with Breast Neoplasms, run by Duke University 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 2 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 13 Apr 2017. 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.
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?
Radiologist ROC (receiver operating characteristic) area under curve (AUC) (time frame: at imaging review by the end of the study, approximately 9 years). 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 13 Apr 2017.