Koning Breast Computed Tomography Guided Biopsy

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Device: Koning Breast CT-guided Biopsy

• Registration Number: NCT01750320
• Lead Sponsor: Koning Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Koning Breast CT - guided Biopsy	Koning Breast CT-guided Biopsy	-

Primary Outcome Measures

Name	Time	Method
The accuracy of Koning breast CT-guided biopsy	about 1 year	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.

Trial Locations

Locations (1)

Elizabeth Wende Breast Care; 🇺🇸 Rochester, New York, United States