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Koning Breast Computed Tomography Guided Biopsy

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ClinicalTrials.gov Identifier: NCT01750320
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Elizabeth Wende Breast Care, LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Koning Breast CT-guided Biopsy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Koning Breast CT-guided Biopsy Phase I Trial
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750320


Locations
United States, New York
Elizabeth Wende Breast Care
Rochester, New York, United States, 14620
Sponsors and Collaborators
Koning Corporation
Elizabeth Wende Breast Care, LLC

Responsible Party: Koning Corporation
ClinicalTrials.gov Identifier: NCT01750320     History of Changes
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) )
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Koning Corporation:
Breast CT
Biopsy