An observational study in Breast Cancer, sponsored by Koning Corporation. Completed at 1 site in United States. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-18.
Sponsored by Koning Corporation · Observational
The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.
Koning Corporation is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will be selected from the patient population at a community based clinic, Elizabeth Wende Breast Care, LLC, which is located in Rochester, NY. Group I will consist of subjects who have had mammograms read as BIRADS® 1 or 2. Group II will be subjects who have had a diagnostic mammogram read as BIRADS® 4 or 5 prior to breast biopsy.
Group I:
Group II:
Exclusion Criteria:
Group I and Group II:
Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
Device: Computed Tomography
Device: Computed Tomography
In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.
Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology
The primary measure of this study will include the following aspects. * the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam * patient's comfort during the CBCT exam vs the mammographic exam * the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies * the concordance and discordance of CBCT breast imaging with histopathology * number of participants with adverse events as a measure of safety
Time frame: about 3 years
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Koning Corporation