Status:
COMPLETED
Cone Beam Computed Tomography for Breast Imaging
Lead Sponsor:
Koning Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
PHASE1
Brief Summary
The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating bo...
Eligibility Criteria
Inclusion
- Group I:
- Are at least 40 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:
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 4 or 5
- Are scheduled for breast biopsy
- Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
- Is able to undergo informed consent.
- Group III:
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 4 or 5
- Are scheduled for breast biopsy
- Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
- Is able to undergo informed consent.
Exclusion
- 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
- Group III:
- 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
- Allergy or previous reaction to iodinated contrast material
- History of renal dysfunction/kidney disease
- Long standing diabetes mellitus
- Multiple myeloma
- Dehydration
- History of nephrotoxic medication use
- Hyperthyroidism
- Diabetic patients on Metformin
- Pheochromocytoma
- Sickle Cell Disease
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00972413
Start Date
June 1 2008
End Date
May 1 2012
Last Update
December 17 2012
Active Locations (1)
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1
Elizabeth Wende Breast Care
Rochester, New York, United States, 14620