Breast CystsNCT01807754
Simulated Screening Study for Breast Imaging
An observational study of Breast Cysts and Breast Tumors, run by University of Michigan at 1 site in United States.
Trial summary
This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities: 1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS) 2. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Breast Cysts, Breast Tumors
- What is being tested?
- X-ray and ultrasound imaging scanning and Photoacoustic imaging scans for breast cancer screening
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 23 Apr 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes women who have had a mammogram at University of Michigan within one year who have been referred to the study. Participants may have a breast mass, either benign or cancerous.
Who may be able to join
- Women with possible masses
- All women should have had mammograms at University of Michigan Health System within 1 year before this research study.
Who cannot join
- Women who are physically unable to tolerate the length of the scan.
- Women who are less than 30 years of age or older than 80 years of age
- Women who are pregnant or lactating
- Women whose mass is in an area of the breast which makes it difficult to see in the research scans
- Womens with a single diagnosis of mammographic calcifications
- Women who have had a breast cancer with lumpectomy
Show all 12Show fewer
- Women who are prisoners
- Women who are students or staff of investigators
- Women who cannot give consent
- Women with mammograms classified as probably benign because of follow-up of a recent benign biopsy.
- Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting and Data System) category 0(incomplete) on their most recent mammograms.
- Males, because their breast tissue is not easily imaged and numbers of potential cases are too few.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:
- Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)
- Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
Read the detailed description
This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:
- Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.
- Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.
- Conditions
- Breast Cysts, Breast Tumors
- Being tested
- X-ray and ultrasound imaging scanning, Photoacoustic imaging scans for breast cancer screening
- Keywords
- automated ultrasound imaging (AUS), digital breast tomosynthesis (DBT), photoacoustic imaging (PAT)
- Medical subject headings
- Breast Cyst, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray and ultrasound imaging scanningProcedure or surgery
Also called Digital tomosynthesis mammogram and automated ultrasound
Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging.
Photoacoustic imaging scans for breast cancer screeningProcedure or surgery
Also called Optoacoustic Imaging
The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast.
| Study group | Role | What they receive |
|---|---|---|
| Imaging scans for breast cancer screening | To simulate the performance of the combination of three new breast imaging systems to digital mammography and hand-held ultrasound that are currently used to find and evaluate breast masses.
These three different systems make images of the breast in several ways to find breast masses and to distinguish normal and abnormal masses. This may result in less unnecessary call-backs from mammography. Receives: Procedure: X-ray and ultrasound imaging scanning; Procedure: Photoacoustic imaging scans for breast cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of new breast imaging devices
To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.
Measured: 3 years
Secondary outcomes (1)
Determining the ratio of "patient call backs"
To determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startDec 2012
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CystsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 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, Univ. of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807754
- Sponsor's protocol ID
- HUM 00069294
- Other IDs
- 2R01CA091713
- Status last verified
- May 2020
- First submitted
- 6 Dec 2012
- Last updated
- 21 May 2020
- 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 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
- ClinicalTrials.gov ID
- NCT01807754
- Acronym / sponsor ID
- HUM 00069294
- Conditions
- Breast Cysts, Breast Tumors
- Keywords
- automated ultrasound imaging (AUS), digital breast tomosynthesis (DBT), photoacoustic imaging (PAT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Dec 2012
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 8 Mar 2013 (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.
This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:
- Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)
- Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
Detailed description
This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:
- Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.
- Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging scans for breast cancer screening | – | Procedure: X-ray and ultrasound imaging scanning, Procedure: Photoacoustic imaging scans for breast cancer screeningTo simulate the performance of the combination of three new breast imaging systems to digital mammography and hand-held ultrasound that are currently used to find and evaluate breast masses. These three different systems make images of the breast in several ways to find breast masses and to distinguish normal and abnormal masses. This may result in less unnecessary call-backs from mammography. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes women who have had a mammogram at University of Michigan within one year who have been referred to the study. Participants may have a breast mass, either benign or cancerous.
Key inclusion criteria (2 listed)
- Women with possible masses
- All women should have had mammograms at University of Michigan Health System within 1 year before this research study.
Key exclusion criteria (12 listed)
- Women who are physically unable to tolerate the length of the scan.
- Women who are less than 30 years of age or older than 80 years of age
- Women who are pregnant or lactating
- Women whose mass is in an area of the breast which makes it difficult to see in the research scans
- Womens with a single diagnosis of mammographic calcifications
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 |
|---|---|---|
| X-ray and ultrasound imaging scanningAlso: Digital tomosynthesis mammogram and automated ultrasoundDigital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging. | Procedure or surgery | Imaging scans for breast cancer screening |
| Photoacoustic imaging scans for breast cancer screeningAlso: Optoacoustic ImagingThe participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast. | Procedure or surgery | Imaging scans for breast cancer screening |
Primary outcome
Evaluation of new breast imaging devices
Time frame: 3 years
To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.
1 secondary outcome
Determining the ratio of "patient call backs"
Time frame: 5 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 21 May 2020.
- 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
Univ. of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cysts and Breast Tumors, 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 2 inclusion and 12 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 21 May 2020. 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?
Evaluation of new breast imaging devices (time frame: 3 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 21 May 2020.