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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner

Intervention Type DEVICE

All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No