Breast TumorNCT00859261
Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound
A study testing Experimental 3D Breast Ultrasound imaging and Experimental Photoacoustic Imaging in people with Breast Tumor and Breast Cysts, run by University of Michigan at 1 site in United States.
Trial summary
The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Tumor, Breast Cysts
- What is being tested?
- Experimental 3D Breast Ultrasound imaging and Experimental Photoacoustic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2015
- 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 30 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women OR
- Women with suspected benign masses who may/or may not be going to biopsy
- Women with cysts where no biopsy is recommended
Who cannot join
- Women who are pregnant
- Women with breast implants
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2D Silicon Transducer-Compression Plates for Breast Ultrasound
The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.
Read the detailed description
To assist in the developement of 3 dimensional breast ultrasound imaging and when possible compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can provide important information not found on mammograms or routine breast ultrasound.
- Conditions
- Breast Tumor, Breast Cysts
- Being tested
- Experimental 3D Breast Ultrasound imaging, Experimental Photoacoustic Imaging
- Medical subject headings
- Breast Neoplasms, Breast Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 3D Breast Ultrasound imagingProcedure or surgery
Subjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete.
Experimental Photoacoustic ImagingProcedure or surgery
Also called Photoacoustic Tomography (PAT)
Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Breast imaging using Ultrasound and Photoacoustic | Experimental | Evaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging. Receives: Procedure: Experimental 3D Breast Ultrasound imaging; Procedure: Experimental Photoacoustic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.
Assess the quality of 3 D ultrasound in comparison to conventional mammography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 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 Carson, Ph.D., Principal investigator, University of Michigan Basic Science Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859261
- Sponsor's protocol ID
- HUM 15464
- Other IDs
- 2R01CA091713, R01CA115267
- Status last verified
- May 2016
- First submitted
- 9 Mar 2009
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2D Silicon Transducer-Compression Plates for Breast Ultrasound
- ClinicalTrials.gov ID
- NCT00859261
- Acronym / sponsor ID
- HUM 15464
- Conditions
- Breast Tumor, Breast Cysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Mar 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Mar 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 study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.
Detailed description
To assist in the developement of 3 dimensional breast ultrasound imaging and when possible compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can provide important information not found on mammograms or routine breast ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast imaging using Ultrasound and Photoacoustic | Experimental | Procedure: Experimental 3D Breast Ultrasound imaging, Procedure: Experimental Photoacoustic ImagingEvaluating 3D ultrasound for breast abnormalities/masses/cysts. This includes ultrasound imaging and possibly photoacoustic imaging. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy women OR
- Women with suspected benign masses who may/or may not be going to biopsy
- Women with cysts where no biopsy is recommended
Key exclusion criteria (3 listed)
- Women who are pregnant
- Women with breast implants
- Prisoners
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 |
|---|---|---|
| Experimental 3D Breast Ultrasound imagingSubjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete. | Procedure or surgery | Breast imaging using Ultrasound and Photoacoustic |
| Experimental Photoacoustic ImagingAlso: Photoacoustic Tomography (PAT)Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete. | Procedure or surgery | Breast imaging using Ultrasound and Photoacoustic |
Primary outcome
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.
Time frame: 1 year
Assess the quality of 3 D ultrasound in comparison to conventional mammography
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 5 May 2016.
- 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 Carson, Ph.D. principal investigator
University of Michigan Basic Science Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental 3D Breast Ultrasound imaging and Experimental Photoacoustic Imaging in people with Breast Tumor and Breast Cysts, 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 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 5 May 2016. 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?
To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging. (time frame: 1 year). 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 5 May 2016.