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Role of 3D Tomography in Breast Cancer

Phase 1/Phase 2
40 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Role of 3D Tomography in Breast Cancer

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Correlation between mammography and breast CT on lesion detection

Outcome Description:

There are two specific aims of this pilot study. One specific aim is to determine if the lesions that are detected by mammography and referred for biopsy, are visible with breast CT. The other specific aim is to determine if there is a correlation between CT numbers and malignancy, in particular for soft tissue (solid masses) abnormalities and to determine if image processing techniques improve correlation between CT numbers and malignancy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Andrew Karellas, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Massachusetts, Worcester


United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • breast cancer, CT scans, mammography
  • Breast Neoplasms



University of Rochester Medical Center, Highland Breast Imaging Center Rochester, New York  14623