Breast CancerNCT00208871
An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
A study testing Stereoscopic Digital Mammography in people with Breast Cancer, run by Emory University at 1 site in United States.
Trial summary
The primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereoscopic Digital Mammography
- Type of treatment
- Surgery or procedure
- How many people
- 1,467 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Mar 2011
- 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
None listed.
Who cannot join
- Patient does not meet any of the inclusion criteria,
- Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
- Patient has suspected or confirmed pregnancy,
- Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer.
Read the detailed description
The clinical trial, begun in December, 2004, is being conducted at Emory University. Over the next three years, we will enroll and image about 2000 women who are at elevated risk for development of breast cancer (personal or family history of breast cancer) as they come in for their annual screening examinations. Each participating patient will be imaged with both systems, and the stereo and standard (non-stereo) images will be read independently by different mammographers.
A stereoscopic digital mammogram consists of two x-ray images of the breast acquired from slightly different points of view on a digital mammography unit. The x-ray source is rotated 10-degrees between the two exposures while the position of the breast remains fixed in the compression device. The stereo pair of mammograms is viewed on a new third-generation, high-resolution stereo display workstation that was developed in the first part of this project. The mammographer views the stereo display wearing lightweight polarized glasses, enabling him or her to see in depth the internal structure within the breast. As a result, a subtle lesion that may be obscured by superimposed normal tissue in a standard 2D image, now becomes visible as the overlying and underlying normal tissue is separated in depth. Conversely, layers of tissue that may falsely resemble a lesion in a standard 2D image due to chance superimposition, are seen in the stereo mammogram to lie at different depths and, thus, will not be mistaken as a lesion.
We anticipate that with stereo mammography the mammographers will detect subtle lesions in the stereo images that are missed in the non-stereo images. We also expect that there will be fewer false positive detections with the stereo images compared to the standard images. Finally, we also expect that the mammographers will be more confident in their judgments of what they see in the stereo images, resulting in a reduced rate of recall of patients for further work-up.
- Conditions
- Breast Cancer
- Being tested
- Stereoscopic Digital Mammography
- Keywords
- Stereoscopic digital mammography, Breast cancer detection, Reduced rate of recall, Focal abnormalities detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereoscopic Digital MammographyProcedure or surgery
screening digital 3D mammogram
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity/specificity
Measured: Aug '04 to Dec '07
Secondary outcomes (1)
Recall rate
Measured: Aug '04 to December '7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Emory 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- BBN Technologies
- Responsible party
- Principal investigator, Carl J. D'Orsi, MD, Emory University
- Investigators
- David J Getty, Ph.D., Principal investigator, BBN TechnologiesCarl J D'Orsi, MD, Principal investigator, Emory School of Medicine Site PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208871
- Sponsor's protocol ID
- IRB00045816
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Getty DJ, Pickett RM, D'Orsi CJ. Stereoscopic digital mammography: improving detection and diagnosis of breast cancer. In: Computer Assisted Radiology and Surgery (CARS-2001). Berlin, Germany: Elsevier Science B.V., 2001.
Getty D. J. Stereoscopic digital mammography. Proceedings of the First Americas Display Engineering and Applications Conference (ADEAC '04), Ft. Worth, 2004, 11-14.
Getty, D. J. Stereoscopic and biplane digital radiography. In E. Samei & M. Flynn (Eds.), RSNA Categorical Course in Diagnostic Radiology Physics: Advances in Digital Radiography. RSNA Publications, 2003; 199-209.
Getty, D. J. Stereoscopic digital mammography: perceptual and display factors leading to improved early detection of breast cancer. In H-O Peitgen (Ed.), Digital Mammography, IWDM 2002, 6th International Workshop on Digital Mammography. Berlin: Springer, 2003, 431-435.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall
- ClinicalTrials.gov ID
- NCT00208871
- Acronym / sponsor ID
- IRB00045816
- Conditions
- Breast Cancer
- Keywords
- Stereoscopic digital mammography, Breast cancer detection, Reduced rate of recall, Focal abnormalities detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,467 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- BBN Technologies
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Sep 2005 (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 primary goal of this study is to compare, within a clinical screening setting, the performance of stereoscopic digital mammography with standard (non-stereo) digital mammography in the detection of abnormalities in the breast, including early breast cancer.
Detailed description
The clinical trial, begun in December, 2004, is being conducted at Emory University. Over the next three years, we will enroll and image about 2000 women who are at elevated risk for development of breast cancer (personal or family history of breast cancer) as they come in for their annual screening examinations. Each participating patient will be imaged with both systems, and the stereo and standard (non-stereo) images will be read independently by different mammographers.
A stereoscopic digital mammogram consists of two x-ray images of the breast acquired from slightly different points of view on a digital mammography unit. The x-ray source is rotated 10-degrees between the two exposures while the position of the breast remains fixed in the compression device. The stereo pair of mammograms is viewed on a new third-generation, high-resolution stereo display workstation that was developed in the first part of this project. The mammographer views the stereo display wearing lightweight polarized glasses, enabling him or her to see in depth the internal structure within the breast. As a result, a subtle lesion that may be obscured by superimposed normal tissue in a standard 2D image, now becomes visible as the overlying and underlying normal tissue is separated in depth. Conversely, layers of tissue that may falsely resemble a lesion in a standard 2D image due to chance superimposition, are seen in the stereo mammogram to lie at different depths and, thus, will not be mistaken as a lesion.
We anticipate that with stereo mammography the mammographers will detect subtle lesions in the stereo images that are missed in the non-stereo images. We also expect that there will be fewer false positive detections with the stereo images compared to the standard images. Finally, we also expect that the mammographers will be more confident in their judgments of what they see in the stereo images, resulting in a reduced rate of recall of patients for further work-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patient does not meet any of the inclusion criteria,
- Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy,
- Patient has suspected or confirmed pregnancy,
- Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit.
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 |
|---|---|---|
| Stereoscopic Digital Mammographyscreening digital 3D mammogram | Procedure or surgery | – |
Primary outcome
sensitivity/specificity
Time frame: Aug '04 to Dec '07
1 secondary outcome
Recall rate
Time frame: Aug '04 to December '7
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 20 Nov 2013.
- BackgroundGetty DJ, Pickett RM, D'Orsi CJ. Stereoscopic digital mammography: improving detection and diagnosis of breast cancer. In: Computer Assisted Radiology and Surgery (CARS-2001). Berlin, Germany: Elsevier Science B.V., 2001.
- BackgroundGetty D. J. Stereoscopic digital mammography. Proceedings of the First Americas Display Engineering and Applications Conference (ADEAC '04), Ft. Worth, 2004, 11-14.
- BackgroundGetty, D. J. Stereoscopic and biplane digital radiography. In E. Samei & M. Flynn (Eds.), RSNA Categorical Course in Diagnostic Radiology Physics: Advances in Digital Radiography. RSNA Publications, 2003; 199-209.
- Results publicationGetty, D. J. Stereoscopic digital mammography: perceptual and display factors leading to improved early detection of breast cancer. In H-O Peitgen (Ed.), Digital Mammography, IWDM 2002, 6th International Workshop on Digital Mammography. Berlin: Springer, 2003, 431-435.
- clinical trials, stereoscopic digital mammographyLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
David J Getty, Ph.D. principal investigator
BBN Technologies
Carl J D'Orsi, MD principal investigator
Emory School of Medicine Site PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereoscopic Digital Mammography in people with Breast Cancer, run by Emory 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 0 inclusion and 4 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 20 Nov 2013. 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?
sensitivity/specificity (time frame: Aug '04 to Dec '07). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208871, which also lists 4 linked publications.
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 20 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.