Role of 3D Tomography in Breast Cancer

University of Rochester

Status: Completed

Conditions: Breast Cancer

Treatments: Device: computed tomography (CT scan)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01090687

URMC-UMASS

1R21CA134128-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.

Enrollment: 150 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
• Able to provide informed consent.

Exclusion criteria

• Males

• 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

Trial design

150 participants in 2 patient groups

Group I Microcalcifications

Description:

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.

Group II Soft tissue findings

Description:

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.

Treatment:

Device: computed tomography (CT scan)

Device: computed tomography (CT scan)