Mammogram ScheduledNCT02008032
Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Breast Augmentation
A study testing Stationary Breast Tomosynthesis in people with Mammogram Scheduled, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast tomosynthesis) and conventional 2-D digital mammography devices with regards to patient comfort and radiologist preference in women with breast implants. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammogram Scheduled
- What is being tested?
- Stationary Breast Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 3 Oct 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women at least 18 years old.
- Able to provide informed consent.
- History of breast augmentation mammoplasty (at least 1 year prior)
Who cannot join
- Male. (It is uncommon for men to present for breast imaging)
- Less than 18 years of age.
- Patient unable to give consent. Institutionalized subject (prisoner or nursing home patient).
- Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating
- Patient with a history of breast cancer (they would not be a screening exam)
- Patient with a known breast cancer (they would not be a screening study)
- Patient with a lump or nipple discharge (diagnostic population)
Trial locations and contacts
1 site in 1 country.
About this study
Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast tomosynthesis) and conventional 2-D digital mammography devices with regards to patient comfort and radiologist preference in women with breast implants.
Participants: Women with breast implants undergoing routine 2-D digital mammography.
Procedures (methods): 50 female subjects with breast implants undergoing conventional screening mammography will be recruited to have a single view s-DBT in the mediolateral projection. We will perform a patient preference study and radiologist reader study composed of radiologists who have experience evaluating tomosynthesis images. A short survey will be given to each patient about their preference in modality with respect to comfort. Each reader will review the images and score the ease of interpretation, and their confidence of interpretation.
Read the detailed description
Patients will be recruited with assistance from a referring physician and through patients undergoing routine mammography in the breast imaging clinic.
All eligible women will be contacted by letter and/or phone call prior to scheduled mammography appointment to identify if they would be interested in participating in the research study. On the day of their conventional mammographic imaging, the study will be explained, and they will be offered the opportunity to participate. Consent will happen in a private room in the mammography clinic.
Once consent has been signed, a urine sample will be collected from women who can still become pregnant in order to complete a pregnancy test. Women who are pregnant are unable to participate in this study.
Women who consent for the study will be escorted by the research coordinator to a dressing room, where the subject will change into a gown. The research coordinator or research technologist will then escort the participant to the dedicated study room for the imaging exam. The patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time.
The breast tomosynthesis scan will be acquired at a dose that is equal to or less than a diagnostic mammogram dose. Upon completion of the breast tomosynthesis exam, the research assistant will provide a short survey to be completed by the patient (less than 5 minutes). The survey will include questions such as the comfort level of s-DBT compared to the standard mammography.
The research SDBT exam will NOT be interpreted prior to the patient leaving the clinic. However, since there is theoretically a possibility of detecting an additional lesion not seen on conventional mammography, all images will be reviewed within a week by a qualified breast imaging specialist. If there are lesions of concern, these will be discussed with the referring surgeon or the patient's primary physician.
After completion of the patient acquisition, a reader study will be performed with five qualified radiologists.
- Conditions
- Mammogram Scheduled
- Being tested
- Stationary Breast Tomosynthesis
- Keywords
- Mammography, Breast, Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary Breast TomosynthesisDevice
The patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Stationary Breast Tomosynthesis Receives: Device: Stationary Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
Receiver Operative Curve (ROC) Area Under the Curve (AUC) analysis of the stationary breast tomosynthesis (SDBT) system for the the characterization of suspicious breast lesions in comparison to x-ray mammography.
Measured: 18 months
Secondary outcomes (2)
Reader preference - arbitrary units
To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.
Measured: 18 months
Patient preference - arbitrary units
To evaluate patient preference of screening methods. Preference will be scored from -3 to +3.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Why it stopped: No patients accrued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammogram ScheduledStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh Lee, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008032
- Sponsor's protocol ID
- 13-1861
- Status last verified
- Jun 2018
- First submitted
- 6 Dec 2013
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Breast Augmentation
- ClinicalTrials.gov ID
- NCT02008032
- Acronym / sponsor ID
- 13-1861
- Conditions
- Mammogram Scheduled
- Keywords
- Mammography, Breast, Implants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients accrued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 11 Dec 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.
Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast tomosynthesis) and conventional 2-D digital mammography devices with regards to patient comfort and radiologist preference in women with breast implants.
Participants: Women with breast implants undergoing routine 2-D digital mammography.
Procedures (methods): 50 female subjects with breast implants undergoing conventional screening mammography will be recruited to have a single view s-DBT in the mediolateral projection. We will perform a patient preference study and radiologist reader study composed of radiologists who have experience evaluating tomosynthesis images. A short survey will be given to each patient about their preference in modality with respect to comfort. Each reader will review the images and score the ease of interpretation, and their confidence of interpretation.
Detailed description
Patients will be recruited with assistance from a referring physician and through patients undergoing routine mammography in the breast imaging clinic.
All eligible women will be contacted by letter and/or phone call prior to scheduled mammography appointment to identify if they would be interested in participating in the research study. On the day of their conventional mammographic imaging, the study will be explained, and they will be offered the opportunity to participate. Consent will happen in a private room in the mammography clinic.
Once consent has been signed, a urine sample will be collected from women who can still become pregnant in order to complete a pregnancy test. Women who are pregnant are unable to participate in this study.
Women who consent for the study will be escorted by the research coordinator to a dressing room, where the subject will change into a gown. The research coordinator or research technologist will then escort the participant to the dedicated study room for the imaging exam. The patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time.
The breast tomosynthesis scan will be acquired at a dose that is equal to or less than a diagnostic mammogram dose. Upon completion of the breast tomosynthesis exam, the research assistant will provide a short survey to be completed by the patient (less than 5 minutes). The survey will include questions such as the comfort level of s-DBT compared to the standard mammography.
The research SDBT exam will NOT be interpreted prior to the patient leaving the clinic. However, since there is theoretically a possibility of detecting an additional lesion not seen on conventional mammography, all images will be reviewed within a week by a qualified breast imaging specialist. If there are lesions of concern, these will be discussed with the referring surgeon or the patient's primary physician.
After completion of the patient acquisition, a reader study will be performed with five qualified radiologists.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Stationary Breast TomosynthesisStationary Breast Tomosynthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women at least 18 years old.
- Able to provide informed consent.
- History of breast augmentation mammoplasty (at least 1 year prior)
Key exclusion criteria (7 listed)
- Male. (It is uncommon for men to present for breast imaging)
- Less than 18 years of age.
- Patient unable to give consent. Institutionalized subject (prisoner or nursing home patient).
- Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating
- Patient with a history of breast cancer (they would not be a screening exam)
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 |
|---|---|---|
| Stationary Breast TomosynthesisThe patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time. | Device | All patients |
Primary outcome
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
Time frame: 18 months
Receiver Operative Curve (ROC) Area Under the Curve (AUC) analysis of the stationary breast tomosynthesis (SDBT) system for the the characterization of suspicious breast lesions in comparison to x-ray mammography.
2 secondary outcomes
Reader preference - arbitrary units
Time frame: 18 months
Patient preference - arbitrary units
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
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.
Yueh Lee, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stationary Breast Tomosynthesis in people with Mammogram Scheduled, run by University of North Carolina, Chapel Hill 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 7 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: withdrawn, as of the sponsor's last update on 28 Jun 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage) (time frame: 18 months). 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 28 Jun 2018.