Breast Neoplasms Clinical Trial
Official title:
Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.
Verified date | April 2017 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | January 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | approximately 18 months | |
Secondary | 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. | approximately 18 months |
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