Koning Breast Computed Tomography Guided Biopsy



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:35 - Any
Updated:4/17/2018
Start Date:August 2012
End Date:December 2015

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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.


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
We found this trial at
1
site
Rochester, New York 14620
?
mi
from
Rochester, NY
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