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

NCT02008032 | Withdrawn

• 1 other identifier: 13-1861
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast tomosynthesis) and conventional 2-D digital mammography devices with regards to patient comfort and radiologist preference in women with breast implants. Participants: Women with breast implants undergoing routine 2-D digital mammography. Procedures (methods): 50 female subjects with breast implants undergoing conventional screening mammography will be recruited to have a single view s-DBT in the mediolateral projection. We will perform a patient preference study and radiologist reader study composed of radiologists who have experience evaluating tomosynthesis images. A short survey will be given to each patient about their preference in modality with respect to comfort. Each reader will review the images and score the ease of interpretation, and their confidence of interpretation.

Conditions

Mammogram Scheduled

Keywords

Mammography; Breast; Implants

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.

  18 months

Secondary Outcomes (2)

• Reader preference - arbitrary units

  18 months

• Patient preference - arbitrary units

  18 months

Study Arms (1)

All patients

EXPERIMENTAL

Stationary Breast Tomosynthesis

Device: Stationary Breast Tomosynthesis

Interventions

Stationary Breast Tomosynthesis DEVICE

The patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women at least 18 years old.
• Able to provide informed consent.
• History of breast augmentation mammoplasty (at least 1 year prior)

You may not qualify if:

• Male. (It is uncommon for men to present for breast imaging)
• 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
• Patient with a history of breast cancer (they would not be a screening exam)
• Patient with a known breast cancer (they would not be a screening study)
• Patient with a lump or nipple discharge (diagnostic population)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Yueh Lee, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2013
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

US (1)