Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773850
• Other study ID #: LCCC-1232
• Status: Completed
• First received: January 4, 2013
• Last updated: March 19, 2018
• Start date: January 2013
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	The University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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