Status:
COMPLETED
Cone Beam CT for Breast Imaging
Lead Sponsor:
Koning Corporation
Collaborating Sponsors:
University of Rochester
Conditions:
Breast Imaging
Breast Cancer
Eligibility:
FEMALE
40+ years
Brief Summary
The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future...
Eligibility Criteria
Inclusion
- Normal Group:
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
- Will undergo study imaging no later than six months from date of routine mammogram.
- Is able to undergo informed consent.
Exclusion
- Pregnancy
- Lactation
- Patients 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.
- Patients who are unable to tolerate study constraints.
- Patients 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 Hodgkin's disease
- Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
- Diagnostic Group:
- Inclusion Criteria:
- Women who are at least 40 years of age of any ethnicity
- Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
- After diagnostic work-up are categorized as BI-RADS® 4 or 5.
- Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
- Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01880580
Start Date
July 1 2006
End Date
June 1 2012
Last Update
June 19 2013
Active Locations (1)
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1
University of Rochester Highland Breast Imaging Center
Rochester, New York, United States, 14620