Cone Beam Computed Tomography for Breast Imaging

Breast Cancer Clinical Trial

Official title:

Cone Beam Computed Tomography for Breast Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107860
• Other study ID #: KBCT-003
• Secondary ID: 2R44CA103236-05A
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2010
• Last updated: June 14, 2013
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Koning Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Elizabeth Wende Breast Care	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
Koning Corporation	Elizabeth Wende Breast Care, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology	The primary measure of this study will include the following aspects.; the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam; patient's comfort during the CBCT exam vs the mammographic exam; the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies; the concordance and discordance of CBCT breast imaging with histopathology; number of participants with adverse events as a measure of safety	about 3 years	Yes