Breast CancerNCT00957567
Comparison Study of Breast Tomosynthesis Slice Thicknesses
An observational study of Breast Cancer, run by Emory University at 1 site in United States.
Trial summary
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2012
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population for this study is women who are recalled for an abnormal finding on a screening mammogram.
3.1 Eligibility Criteria All subjects will be women at least 35 years of age that have been found, after diagnostic workup, to have focal distributions of microcalcifications (BI-RADS 3, 4 or 5), focal soft tissue lesions (BI-RADS 3, 4 or 5), or no findings (BI-RADS 1).
3.2 Ineligibility Criteria
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women with large breasts that cannot be accommodated within the field of view of the tomosynthesis system
- Women who are very frail and unable to cooperate
- Women who are under 35 years of age
- Women who cannot give informed consent
- Male subjects
- Women with implants
- Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital Breast Imaging Center
Atlanta, Georgia, 30322
About this study
Official title: A Comparison Study of Breast Tomosynthesis Images Reconstructed at 1 Millimeter and 5 Millimeter Slice Thicknesses
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. Since tomosynthesis images of the breast show the tissues in their real position, the radiologist should be able to more easily find a tumor and also be able to reduce the number of time he or she thinks there is a tumor present when in reality there is not one there.
Before this new technology can be used in the clinic routinely, it is necessary to perform a large number of studies to find the optimal way to use it. In this study, the investigators are aiming to find how thick the slices or layers representing the breast should be in the image when shown to the radiologist. The difference between these two thicknesses in how useful the images are to the radiologist could be important. The investigators are trying to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, the investigators will image patients with their tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. The investigators hope to find that the thicker slices help more than the thinner slices when trying to decide if biopsy is needed or not.
Read the detailed description
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. The flat images in mammograms bring about the possibility that normal healthy tissue sometimes covers up malignant tumors, making them harder, and sometimes impossible, for the physician to see. In addition, this "flattening" sometimes generates what appears to be suspicious tissue, but is in reality a superposition of normal healthy tissue. This effect results in performing an increased number of biopsies that end up being negative for breast cancer. Since tomosynthesis images of the breast show the tissues in their real position, these effects can be avoided. It has already been shown by various research labs, including ours, that this kind of imaging does in fact result in better visualization of lesions compared to conventional two-dimensional imaging, even without performing tomosynthesis under ideal conditions.
For tomosynthesis to reach its full potential, it is necessary to perform a large number of studies to find the optimal way to acquire the tomosynthesis images and the optimal way to mathematically combine these images to get the three dimensional image. In this study, we are aiming to find if the resulting three dimensional image should be divided into slices or layers each representing 1 millimeter (less than one 16th of an inch) of the breast or 5 millimeters (one 5th of an inch) of the breast. The difference between these two thicknesses in how useful the images are to the radiologist could be important. Up to now, tomosynthesis imaging has been performed with 1 millimeter slices, but there has been no scientific study to prove that this is the best slice thickness. We will try to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, we will image patients with our tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. We hope to show that the images with the thick slices will do as well if not better than those with the thin slices. Even if the thick slices only do as well as the thin slices, this will show that creating images with thicker slices is better, since these images can be read faster by the radiologist.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence in diagnostic accuracy
Measured: After biopsy or follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionDec 2012
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Principal investigator, Mary Newell, MD, Emory University
- Investigators
- Mary Newell, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957567
- Sponsor's protocol ID
- IRB00008667
- Status last verified
- Nov 2013
- First submitted
- 11 Aug 2009
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Breast Tomosynthesis Images Reconstructed at 1 Millimeter and 5 Millimeter Slice Thicknesses
- ClinicalTrials.gov ID
- NCT00957567
- Acronym / sponsor ID
- IRB00008667
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Aug 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.
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. Since tomosynthesis images of the breast show the tissues in their real position, the radiologist should be able to more easily find a tumor and also be able to reduce the number of time he or she thinks there is a tumor present when in reality there is not one there.
Before this new technology can be used in the clinic routinely, it is necessary to perform a large number of studies to find the optimal way to use it. In this study, the investigators are aiming to find how thick the slices or layers representing the breast should be in the image when shown to the radiologist. The difference between these two thicknesses in how useful the images are to the radiologist could be important. The investigators are trying to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, the investigators will image patients with their tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. The investigators hope to find that the thicker slices help more than the thinner slices when trying to decide if biopsy is needed or not.
Detailed description
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. The flat images in mammograms bring about the possibility that normal healthy tissue sometimes covers up malignant tumors, making them harder, and sometimes impossible, for the physician to see. In addition, this "flattening" sometimes generates what appears to be suspicious tissue, but is in reality a superposition of normal healthy tissue. This effect results in performing an increased number of biopsies that end up being negative for breast cancer. Since tomosynthesis images of the breast show the tissues in their real position, these effects can be avoided. It has already been shown by various research labs, including ours, that this kind of imaging does in fact result in better visualization of lesions compared to conventional two-dimensional imaging, even without performing tomosynthesis under ideal conditions.
For tomosynthesis to reach its full potential, it is necessary to perform a large number of studies to find the optimal way to acquire the tomosynthesis images and the optimal way to mathematically combine these images to get the three dimensional image. In this study, we are aiming to find if the resulting three dimensional image should be divided into slices or layers each representing 1 millimeter (less than one 16th of an inch) of the breast or 5 millimeters (one 5th of an inch) of the breast. The difference between these two thicknesses in how useful the images are to the radiologist could be important. Up to now, tomosynthesis imaging has been performed with 1 millimeter slices, but there has been no scientific study to prove that this is the best slice thickness. We will try to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, we will image patients with our tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. We hope to show that the images with the thick slices will do as well if not better than those with the thin slices. Even if the thick slices only do as well as the thin slices, this will show that creating images with thicker slices is better, since these images can be read faster by the radiologist.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study is women who are recalled for an abnormal finding on a screening mammogram.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Equivalence in diagnostic accuracy
Time frame: After biopsy or follow-up
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 Nov 2013.
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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.
Mary Newell, MD principal investigator
Emory University
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 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?
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 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?
Equivalence in diagnostic accuracy (time frame: After biopsy or follow-up). 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 Nov 2013.