Cone Beam Computed Tomography for Breast Imaging
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 5/27/2013 |
| Start Date: | January 2010 |
| End Date: | June 2013 |
| Contact: | Posy Seifert, D.O. |
| Email: | pseifert@ewbc.com |
| Phone: | 585-442-8029 |
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.
Inclusion Criteria:
Group I:
- Females at least 35 years of age of any ethnicity
- Had a mammogram, read as BI-RADS® 1 or 2
- Will undergo study imaging no later than four weeks from date of mammogram.
- Is able to undergo informed consent.
Group II:
- Females at least 35 years of age of any ethnicity
- Require diagnostic imaging
- Will undergo study imaging no later than four weeks from date of diagnostic mammogram
- Is able to undergo informed consent
Exclusion Criteria:
Group I and Group II:
- Pregnancy
- Lactation
- Subjects with physical limitations that may prohibit resting prone on the exam table,
such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- 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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