Cone Beam Computed Tomography for Breast Imaging

NCT ID: NCT01107860

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 401 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I

Computed Tomography

Intervention Type: DEVICE

In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.

Group II

Computed Tomography

Intervention Type: DEVICE

In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.

Interventions

Computed Tomography

In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.

Intervention Type: DEVICE

Computed Tomography

In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Elizabeth Wende Breast Care, LLC

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Koning Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Posy Seifert, D.O.

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Wende Breast Care, LLC

Locations

Elizabeth Wende Breast Care

Rochester, New York, United States

Countries

United States

Other Identifiers

2R44CA103236-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KBCT-003

Identifier Type: -

Identifier Source: org_study_id