Breast CancerNCT00721435
Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
A study testing 3D Tomosynthesis and ultrasound imaging in people with Breast Cancer and Mass Cystic, run by University of Michigan at 2 sites in United States.
Trial summary
The study will evaluate and refine a breast screening and diagnosis device. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mass Cystic, Benign Mass
- What is being tested?
- 3D Tomosynthesis and ultrasound imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2002to Oct 2016
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To participate in this research study you must be a female over the age of 25
- Have had a normal mammogram or are scheduled for a breast biopsy
- Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.
Who cannot join
- Male
- Under the age of 25
- Documented breast cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109-0554
University of Michigan
Ann Arbor, Michigan, 48109
About this study
The study will evaluate and refine a breast screening and diagnosis device.
Read the detailed description
The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.
- Conditions
- Breast Cancer, Mass Cystic, Benign Mass
- Being tested
- 3D Tomosynthesis and ultrasound imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Tomosynthesis and ultrasound imagingProcedure or surgery
3D tomosynthesis \& ultrasound imaging for scanning masses or healthy breast tissue
| Study group | Role | What they receive |
|---|---|---|
| 3D Tomosynthesis & 3D Ultrasound for breast masses | Experimental | Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound. Receives: Procedure: 3D Tomosynthesis and ultrasound imaging |
| 3D Tomosynthesis/ 3D Ultrasound for healthy subjects | Experimental | Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound. Receives: Procedure: 3D Tomosynthesis and ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.
Measured: To be determined later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startApr 2002
- Primary completionDec 2014
- Study completionOct 2016
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.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul L. Carson Ph.D, University of Michigan
- Investigators
- Paul L Carson, PHD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721435
- Sponsor's protocol ID
- HUM00045519 (2002-0584)
- Other IDs
- R01CA091713
- Status last verified
- Jan 2017
- First submitted
- 22 Jul 2008
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
- ClinicalTrials.gov ID
- NCT00721435
- Acronym / sponsor ID
- HUM00045519 (2002-0584)
- Conditions
- Breast Cancer, Mass Cystic, Benign Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Apr 2002
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 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 study will evaluate and refine a breast screening and diagnosis device.
Detailed description
The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Tomosynthesis & 3D Ultrasound for breast masses | Experimental | Procedure: 3D Tomosynthesis and ultrasound imagingEvaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound. |
| 3D Tomosynthesis/ 3D Ultrasound for healthy subjects | Experimental | Procedure: 3D Tomosynthesis and ultrasound imagingEvaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To participate in this research study you must be a female over the age of 25
- Have had a normal mammogram or are scheduled for a breast biopsy
- Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.
Key exclusion criteria (3 listed)
- Male
- Under the age of 25
- Documented breast cancer
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 |
|---|---|---|
| 3D Tomosynthesis and ultrasound imaging3D tomosynthesis \& ultrasound imaging for scanning masses or healthy breast tissue | Procedure or surgery | 3D Tomosynthesis & 3D Ultrasound for breast masses, 3D Tomosynthesis/ 3D Ultrasound for healthy subjects |
Primary outcome
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.
Time frame: To be determined later.
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 24 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Paul L Carson, PHD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Tomosynthesis and ultrasound imaging in people with Breast Cancer and Mass Cystic, run by University of Michigan at 2 sites 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 3 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position. (time frame: To be determined later.). 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 24 Jan 2017.