Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2010-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group I Microcalcifications
After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan.
computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan
Group II Soft tissue findings
After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan.
computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan
Interventions
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computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan
computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent.
Exclusion Criteria
* Women less than 40 years old
* Pregnant women
* Lactating women
* Woman who have had bilateral mastectomies
* Women 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
* Women who are unable to tolerate study constraints, frail or unable to cooperate
* Women with large breasts that cannot be accommodated within the field of view of the CT system
* Women 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
* Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
* Tuberculosis
* Severe scoliosis
40 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Principal Investigators
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Andrew Karellas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Stephen Glick, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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University of Rochester Medical Center, Highland Breast Imaging Center
Rochester, New York, United States
Countries
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Other Identifiers
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URMC-UMASS
Identifier Type: -
Identifier Source: org_study_id