Breast CancerNCT00957307
Breast Computed Tomography (CT) as a Diagnostic Tool
An observational study of Breast Cancer, run by Emory University at 1 site in United States.
Trial summary
Lay Summary The American Cancer Society has recommended that all women over the age of 40 have an annual mammogram for many years. This recommendation has been associated with a substantial decrease in breast cancer deaths. 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jan 2015
- 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: Women having breast biopsy for either masses or calcifications
Who may be able to join
- 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 4 or 5) or focal soft tissue lesions (BI-RADS 4 or 5)
Who cannot join
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women who are very frail and unable to cooperate
- Women who are under 35 years of age
- Women who cannot give informed consent
Show all 11Show fewer
- Male subjects
- Women with implants
- Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy
- Women recalled for bilateral workup
- Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems, or any other condition that would prohibit them from lying face down
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: Breast CT as a Diagnostic Tool
Lay Summary
The American Cancer Society has recommended that all women over the age of 40 have an annual mammogram for many years. This recommendation has been associated with a substantial decrease in breast cancer deaths. When something suspicious is seen in one of these mammograms, the woman is called back to the clinic for more imaging tests to better determine if that suspicious feature might be breast cancer. These additional imaging tests include repeated mammograms, magnification mammograms and/or ultrasound. Depending on what is seen in these images, the radiologist will provide a diagnosis that the suspicion is probably cancer, probably benign, or that the suspicion is a "false alarm." If it is a false alarm, then the woman is sent home and she should come back after a year for another standard annual mammogram. If the diagnosis is that it is probably benign, then the woman should come back after 6 months so that the suspicion can be tested again. If the diagnosis is that it is probably cancer, the woman is recommended to have a biopsy so that the cancer can be confirmed. Both fortunately and unfortunately, 80% of the biopsies turn out to be "false alarms." Although confirming that a woman does not have cancer is always a very good thing, having put her through the anxiety, expense, and risk of a biopsy for what turned out to be nothing should be avoided. Therefore, it would be desirable to reduce the number of unnecessary biopsies that are performed.
Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. The investigators propose to use breast CT as a new, better tool for the radiologist to perform the diagnosis, and therefore hopefully result in fewer biopsies, which should decrease the "false alarms." Before breast CT can be used clinically as a diagnostic tool, extensive testing must be performed. In this first step, the investigators propose to acquire breast CT images of only 10 patients that have been recommended to have biopsies, to see if the radiologist would have arrived at a different diagnosis if he/she had based his/her decision on the breast CT images. Since this has never been attempted before, this is an initial small study to test the feasibility of this method.
Read the detailed description
See Brief Summary
- 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.
Reduction in negative biopsies
Measured: After biopsy
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 startMay 2009
- Primary completionJan 2010
- Study completionJan 2015
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 only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Sechopoulos, Ph.D., Emory University
- Investigators
- Ioannis Sechopoulos, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957307
- Sponsor's protocol ID
- IRB00014006
- Status last verified
- Jul 2015
- First submitted
- 11 Aug 2009
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast CT as a Diagnostic Tool
- ClinicalTrials.gov ID
- NCT00957307
- Acronym / sponsor ID
- IRB00014006
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2015 (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.
Lay Summary
The American Cancer Society has recommended that all women over the age of 40 have an annual mammogram for many years. This recommendation has been associated with a substantial decrease in breast cancer deaths. When something suspicious is seen in one of these mammograms, the woman is called back to the clinic for more imaging tests to better determine if that suspicious feature might be breast cancer. These additional imaging tests include repeated mammograms, magnification mammograms and/or ultrasound. Depending on what is seen in these images, the radiologist will provide a diagnosis that the suspicion is probably cancer, probably benign, or that the suspicion is a "false alarm." If it is a false alarm, then the woman is sent home and she should come back after a year for another standard annual mammogram. If the diagnosis is that it is probably benign, then the woman should come back after 6 months so that the suspicion can be tested again. If the diagnosis is that it is probably cancer, the woman is recommended to have a biopsy so that the cancer can be confirmed. Both fortunately and unfortunately, 80% of the biopsies turn out to be "false alarms." Although confirming that a woman does not have cancer is always a very good thing, having put her through the anxiety, expense, and risk of a biopsy for what turned out to be nothing should be avoided. Therefore, it would be desirable to reduce the number of unnecessary biopsies that are performed.
Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. The investigators propose to use breast CT as a new, better tool for the radiologist to perform the diagnosis, and therefore hopefully result in fewer biopsies, which should decrease the "false alarms." Before breast CT can be used clinically as a diagnostic tool, extensive testing must be performed. In this first step, the investigators propose to acquire breast CT images of only 10 patients that have been recommended to have biopsies, to see if the radiologist would have arrived at a different diagnosis if he/she had based his/her decision on the breast CT images. Since this has never been attempted before, this is an initial small study to test the feasibility of this method.
Detailed description
See Brief Summary
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women having breast biopsy for either masses or calcifications
Key inclusion criteria (1 listed)
- 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 4 or 5) or focal soft tissue lesions (BI-RADS 4 or 5)
Key exclusion criteria (11 listed)
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women who are very frail and unable to cooperate
- Women who are under 35 years of age
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
Reduction in negative biopsies
Time frame: After biopsy
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 23 Jul 2015.
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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.
Ioannis Sechopoulos, PhD 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?
The sponsor lists 1 inclusion and 11 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 23 Jul 2015. 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?
Reduction in negative biopsies (time frame: After biopsy). 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 23 Jul 2015.