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 |
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.
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
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