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

Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01773850

Enrollment

Registered

2013-01-23

Start date

2013-01-31

Completion date

2018-01-31

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

breast cancer

Brief 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.

Interventions

DEVICEStationary 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)	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.

Secondary

Measure	Time frame	Description
Reader preference - arbitrary units	approximately 18 months	To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026