Koning Breast Computed Tomography Guided Biopsy
Completed · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01750320
- Run by
- Koning Corporation
- People needed
- 4
- Starts
- 2012-08-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2018-03-07
Who can join
Age: 35 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Elizabeth Wende Breast Care — Rochester, New York, United States
Full record on ClinicalTrials.gov
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