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Completed

NCT Number: NCT01750320

Koning Breast Computed Tomography Guided Biopsy

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.

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Key information

Conditions

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

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Koning Breast CT-guided Biopsy

Device

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.

Primary outcomes

  1. The accuracy of Koning breast CT-guided biopsy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Koning Corporation

Industry

Collaborators

  • Elizabeth Wende Breast Care, LLC

Registry information

Official study title

Koning Breast CT-guided Biopsy Phase I Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2012
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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