Cone Beam CT for Breast Imaging

Koning Health

Status: Completed

Conditions: Breast Cancer; Breast Imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01880580

URMC-001

Details and patient eligibility

About

The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.

Enrollment: 76 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Normal Group:

Inclusion Criteria:

• Are at least 40 years of age of any ethnicity
• Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
• Will undergo study imaging no later than six months from date of routine mammogram.
• Is able to undergo informed consent.

Exclusion Criteria:

• Pregnancy

• Lactation

• Patients 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.

• Patients who are unable to tolerate study constraints.

• Patients 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

• Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

• Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  • Tuberculosis
  • Severe scoliosis

Diagnostic Group:

Inclusion Criteria:

• Women who are at least 40 years of age of any ethnicity
• Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
• After diagnostic work-up are categorized as BI-RADS® 4 or 5.
• Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
• Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.

Exclusion Criteria:

• Pregnancy

• Lactation

• Patients who have already undergone biopsy for the index lesion

• Patients who are unable or unwilling to undergo biopsy for the lesion of concern

• Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.

• Patients who are unable to tolerate study constraints.

• Patients who have received radiation treatments to the thorax or breast area 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

• Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

• Patients 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

76 participants in 2 patient groups

Normal Group

Description:

In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information.

Diagnostic Group

Description:

The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5). Forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.