Koning Breast Computed Tomography Guided Biopsy
March 5, 2018 updated by: Koning Corporation
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14620
- Elizabeth Wende Breast Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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.
|
about 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.