Koning Breast Computed Tomography Guided Biopsy

Koning Breast CT-guided Biopsy Phase I Trial

The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Koning Breast CT-guided Biopsy

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Elizabeth Wende Breast Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female at least 35 years of age of any ethnicity
• Lesion seen on mammography
• Diagnostic report read as BI-RADS 4 or 5
• Will undergo biopsy no later than four weeks from date of mammogram
• Is able to undergo informed consent

Exclusion Criteria:

• Pregnancy
• Lactation
• Subjects with breast implants
• Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pacemaker.
• Subjects who are unable to tolerate study constraints.

• Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  • Treatment for enlarged thymus gland as an infant
  • Irradiation for benign breast conditions, including breast inflammation after giving birth
  • Treatment for Hodgkins disease
• Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

• Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  • Tuberculosis
  • Severe scoliosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Koning Breast CT - guided Biopsy	Device: Koning Breast CT-guided Biopsy; The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of Koning breast CT-guided biopsy	The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.	about 1 year

Collaborators and Investigators

• Sponsor: Koning Corporation
• Collaborators: Elizabeth Wende Breast Care, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Biopsy; Breast CT
• Other Study ID Numbers: KBCT-004; W81XWH-09-1-0441 (Other Grant/Funding Number: Department of Defense (DOD) Telemedicine and Advanced Technology Research Center (TATRC))