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

NCT01773850 | Completed

• 1 other identifier: LCCC-1232
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reader preference - arbitrary units

  approximately 18 months

Study Arms (1)

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.

Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner

Interventions

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.

Also known as: Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgical breast biopsies for lesions detected on mammograms.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related 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.

  PMID: 22482630 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yueh Z Lee, MD,PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Cherie M Kuzmiak, DO

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 23, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2017-04

Locations

US (1)