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OpenTrials
Completed

NCT Number: NCT01773850

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

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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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner

Device

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

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

Primary outcomes

  1. Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)

    Time frame: 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 outcomes

  1. Reader preference - arbitrary units

    Time frame: approximately 18 months

    To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jan 23, 2013
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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