Breast CancerNCT00467727
Visibility of Lesion Characteristics With Phase Contrast Mammography
A study testing Phase Contrast Mammography in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Phase Contrast Mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2008
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 40 years old
- Female
- Scheduled for diagnostic work-up including compression/magnification views of screening detected breast lesion
Who cannot join
- < age 40
- Male
- No screening detected findings
- Breast implants
- Any women who is pregnant or has reason to believe she is pregnant or lactating
- Women with breasts larger than the 24 x 30 cm receptor
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Center for Clinical Trials, University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography
To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM).
Read the detailed description
The ability to detect lesions in mammography before they can be felt is the benefit of using this imaging modality for screening of breast cancer. Screening mammography has been proven to decrease mortality from breast cancer. Radiologists identify abnormal breast tissue in the form of microcalcifications, masses, architectural distortion, and asymmetric density by careful assessment of the characteristics of these types of lesions using the Breast Imaging Reporting and Diagnostic System (BIRADS). BIRADS was developed to provide standardization of reporting of mammographic exams. In screening mammography, while it is possible to detect lesions, often more detailed diagnostic imaging is necessary to improve the visibility of margins and edges of lesions through magnification and compression views of the lesion of interest due to spatial resolution limitations which causes geometric blurring of edges in x-ray mammography.
If the ability to clearly see margins and edges of lesions is possible at screening mammography, this would potentially decrease the overall radiation exposure currently needed to allow radiologists to be confident of their characterizations for the majority of patients using x-ray mammography. Digital mammography was developed to improve the visibility of lesions primarily in dense breasts. The reasoning was that the improved contrast range would allow for wider range of gray level differentiation but with digital mammography comes a spatial resolution limitation that blurred edges of lesions. Phase contrast mammography (PCM) was developed to improve digital mammography by providing improvement in sharpness of edges utilizing the x-ray properties of refraction.
Comparison: Phase Contrast Mammography to X-Ray Mammography for Lesion Visibility of Diagnostic Population
- Conditions
- Breast Cancer
- Being tested
- Phase Contrast Mammography
- Keywords
- Diagnostic Mammography, Breast Imaging, Phase Contrast Mammography, X-Ray Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase Contrast MammographyOther
Standard and magnification views
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Phase Contrast Mammography Exam Receives: Other: Phase Contrast Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etta D Pisano, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467727
- Sponsor's protocol ID
- LCCC0702
- Status last verified
- Apr 2012
- First submitted
- 29 Apr 2007
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1.
PubMed 12727392Tanaka T, Honda C, Matsuo S, Noma K, Oohara H, Nitta N, Ota S, Tsuchiya K, Sakashita Y, Yamada A, Yamasaki M, Furukawa A, Takahashi M, Murata K. The first trial of phase contrast imaging for digital full-field mammography using a practical molybdenum x-ray tube. Invest Radiol. 2005 Jul;40(7):385-96. doi: 10.1097/01.rli.0000165575.43381.48.
PubMed 15973129Pisano ED, Cole EB, Major S, Zong S, Hemminger BM, Muller KE, Johnston RE, Walsh R, Conant E, Fajardo LL, Feig SA, Nishikawa RM, Yaffe MJ, Williams MB, Aylward SR. Radiologists' preferences for digital mammographic display. The International Digital Mammography Development Group. Radiology. 2000 Sep;216(3):820-30. doi: 10.1148/radiology.216.3.r00se48820.
PubMed 10966717
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography
- ClinicalTrials.gov ID
- NCT00467727
- Acronym / sponsor ID
- LCCC0702
- Conditions
- Breast Cancer
- Keywords
- Diagnostic Mammography, Breast Imaging, Phase Contrast Mammography, X-Ray Mammography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 May 2007 (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.
To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM).
Detailed description
The ability to detect lesions in mammography before they can be felt is the benefit of using this imaging modality for screening of breast cancer. Screening mammography has been proven to decrease mortality from breast cancer. Radiologists identify abnormal breast tissue in the form of microcalcifications, masses, architectural distortion, and asymmetric density by careful assessment of the characteristics of these types of lesions using the Breast Imaging Reporting and Diagnostic System (BIRADS). BIRADS was developed to provide standardization of reporting of mammographic exams. In screening mammography, while it is possible to detect lesions, often more detailed diagnostic imaging is necessary to improve the visibility of margins and edges of lesions through magnification and compression views of the lesion of interest due to spatial resolution limitations which causes geometric blurring of edges in x-ray mammography.
If the ability to clearly see margins and edges of lesions is possible at screening mammography, this would potentially decrease the overall radiation exposure currently needed to allow radiologists to be confident of their characterizations for the majority of patients using x-ray mammography. Digital mammography was developed to improve the visibility of lesions primarily in dense breasts. The reasoning was that the improved contrast range would allow for wider range of gray level differentiation but with digital mammography comes a spatial resolution limitation that blurred edges of lesions. Phase contrast mammography (PCM) was developed to improve digital mammography by providing improvement in sharpness of edges utilizing the x-ray properties of refraction.
Comparison: Phase Contrast Mammography to X-Ray Mammography for Lesion Visibility of Diagnostic Population
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Phase Contrast MammographyPhase Contrast Mammography Exam |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 40 years old
- Female
- Scheduled for diagnostic work-up including compression/magnification views of screening detected breast lesion
Key exclusion criteria (6 listed)
- < age 40
- Male
- No screening detected findings
- Breast implants
- Any women who is pregnant or has reason to believe she is pregnant or lactating
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 |
|---|---|---|
| Phase Contrast MammographyStandard and magnification views | Other | 1 |
Primary outcome
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.
Time frame: 12 months
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 1 May 2012.
- Background: PubMed 12727392Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1.
- Background: PubMed 15973129Tanaka T, Honda C, Matsuo S, Noma K, Oohara H, Nitta N, Ota S, Tsuchiya K, Sakashita Y, Yamada A, Yamasaki M, Furukawa A, Takahashi M, Murata K. The first trial of phase contrast imaging for digital full-field mammography using a practical molybdenum x-ray tube. Invest Radiol. 2005 Jul;40(7):385-96. doi: 10.1097/01.rli.0000165575.43381.48.
- Background: PubMed 10966717Pisano ED, Cole EB, Major S, Zong S, Hemminger BM, Muller KE, Johnston RE, Walsh R, Conant E, Fajardo LL, Feig SA, Nishikawa RM, Yaffe MJ, Williams MB, Aylward SR. Radiologists' preferences for digital mammographic display. The International Digital Mammography Development Group. Radiology. 2000 Sep;216(3):820-30. doi: 10.1148/radiology.216.3.r00se48820.
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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.
Etta D Pisano, MD 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 Phase Contrast Mammography in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 6 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 1 May 2012. 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?
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. (time frame: 12 months). 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 NCT00467727, which also lists 3 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 1 May 2012.