Koning Breast Computed Tomography Guided Biopsy

Breast Cancer Clinical Trial

Official title:

Koning Breast CT-guided Biopsy Phase I Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750320
• Other study ID #: KBCT-004
• Secondary ID: W81XWH-09-1-0441
• Status: Completed
• Phase: Phase 1
• First received: December 12, 2012
• Last updated: March 5, 2018
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: Koning Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Elizabeth Wende Breast Care	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Koning Corporation	Elizabeth Wende Breast Care, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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