Cone Beam Computed Tomography for Breast Imaging

Koning Health

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Computed Tomography

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01107860

KBCT-003

2R44CA103236-05A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

401 participants in 2 patient groups

Group I

Treatment:

Device: Computed Tomography

Device: Computed Tomography

Group II

Treatment:

Device: Computed Tomography

Device: Computed Tomography