Cone Beam CT for Breast Imaging
Completed
Conditions studied: Breast Imaging, Breast Cancer
In brief
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 extensive clinical trials.
Key facts
- Study ID
- NCT01880580
- Run by
- Koning Corporation
- People needed
- 76
- Starts
- 2006-07-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2013-06-19
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Exclusion Criteria:
- Pregnancy
- Lactation
- Patients who have already undergone biopsy for the index lesion
- Patients who are unable or unwilling to undergo biopsy for the lesion of concern
- Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
Where it is running
- University of Rochester Highland Breast Imaging Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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