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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

approximately 18 months

Safety Issue:

No

Principal Investigator

Yueh Z Lee, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

LCCC-1232

NCT ID:

NCT01773850

Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location
The University of North Carolina Chapel Hill, North Carolina  27599