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NCT01773850
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Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2015 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01773850
First received: January 4, 2013
Last updated: August 26, 2015
Last verified: August 2015
History of Changes
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Purpose
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.
Condition | Intervention |
---|---|
Breast Neoplasms |
Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner |
Study Type: | Observational |
Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
Official Title: | Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions. |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Mammography
X-Rays
U.S. FDA Resources
Further study details as provided by UNC Lineberger Comprehensive Cancer Center:
Primary Outcome Measures:
- Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage) [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Reader preference - arbitrary units [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.
Estimated Enrollment: | 100 |
Study Start Date: | January 2013 |
Estimated Study Completion Date: | June 2016 |
Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
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.
|
Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.
Other Name: Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study Population
Patients undergoing surgical breast biopsies for lesions detected on mammograms.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773850
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773850
Contacts
Contact: Yueh Z Lee, MD,PhD | 919-537-3730 | leey@med.unc.edu |
Locations
United States, North Carolina | |
The University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: Yueh Z Lee, MD,PhD |
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: | Yueh Z Lee, MD,PhD | University of North Carolina, Chapel Hill | |
Principal Investigator: | Cherie M Kuzmiak, DO | University of North Carolina, Chapel Hill |
More Information
Publications:
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 11, 2016
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.
Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01773850 History of Changes |
Other Study ID Numbers: | LCCC-1232 |
Study First Received: | January 4, 2013 |
Last Updated: | August 26, 2015 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases |
ClinicalTrials.gov processed this record on January 11, 2016
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