Breast NeoplasmsNCT01773850
Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
An observational study of Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgical breast biopsies for lesions detected on mammograms.
Who may be able to join
- Women at least 18 years old.
- Scheduled for breast biopsy of at least one breast lesion.
- Lesion detected on mammogram.
- Symptomatic by patient self-report, patient self-breast exam or clinical exam.
- Able to provide informed consent.
Who cannot join
- Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents <1% of newly diagnosed breast cancer)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.
The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.
- Conditions
- Breast Neoplasms
- Being tested
- Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis ScannerDevice
Also called Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner
All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with a breast lesion undergoing surgical biopsy. All patients will undergo stationary Carbon Nanotube x-ray digital breast tomosynthesis imaging in addition to routine conventional digital mammography. Receives: Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner |
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: approximately 18 months
Secondary outcomes (1)
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: approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yueh Z Lee, MD,PhD, Principal investigator, University of North Carolina, Chapel HillCherie M Kuzmiak, DO, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773850
- Sponsor's protocol ID
- LCCC-1232
- Status last verified
- Apr 2017
- First submitted
- 4 Jan 2013
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Qian X, Tucker A, Gidcumb E, Shan J, Yang G, Calderon-Colon X, Sultana S, Lu J, Zhou O, Spronk D, Sprenger F, Zhang Y, Kennedy D, Farbizio T, Jing Z. High resolution stationary digital breast tomosynthesis using distributed carbon nanotube x-ray source array. Med Phys. 2012 Apr;39(4):2090-9. doi: 10.1118/1.3694667.
PubMed 22482630
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.
- ClinicalTrials.gov ID
- NCT01773850
- Acronym / sponsor ID
- LCCC-1232
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 23 Jan 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.
The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis ScannerPatients with a breast lesion undergoing surgical biopsy. All patients will undergo stationary Carbon Nanotube x-ray digital breast tomosynthesis imaging in addition to routine conventional digital mammography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical breast biopsies for lesions detected on mammograms.
Key inclusion criteria (5 listed)
- Women at least 18 years old.
- Scheduled for breast biopsy of at least one breast lesion.
- Lesion detected on mammogram.
- Symptomatic by patient self-report, patient self-breast exam or clinical exam.
- Able to provide informed consent.
Key exclusion criteria (5 listed)
- Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents <1% of newly diagnosed breast cancer)
- 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
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 Carbon Nanotube X-ray Digital Breast Tomosynthesis ScannerAlso: Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) ScannerAll patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device. | Device | Patients |
Primary outcome
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
Time frame: approximately 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.
1 secondary outcome
Reader preference - arbitrary units
Time frame: approximately 18 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 20 Mar 2018.
- Background: PubMed 22482630Qian X, Tucker A, Gidcumb E, Shan J, Yang G, Calderon-Colon X, Sultana S, Lu J, Zhou O, Spronk D, Sprenger F, Zhang Y, Kennedy D, Farbizio T, Jing Z. High resolution stationary digital breast tomosynthesis using distributed carbon nanotube x-ray source array. Med Phys. 2012 Apr;39(4):2090-9. doi: 10.1118/1.3694667.
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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.
Yueh Z Lee, MD,PhD principal investigator
University of North Carolina, Chapel Hill
Cherie M Kuzmiak, DO 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?
An observational study of Breast Neoplasms, 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 5 inclusion and 5 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 Mar 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 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?
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage) (time frame: approximately 18 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 NCT01773850, which also lists 1 linked publication.
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 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.