Role of 3D Tomography in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Rochester Medical Center, Highland Breast Imaging Center

Rochester, New York, 14623, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computed tomography (CT scan)

Radiation

Subjects will undergo cone beam breast CT scan

Other names: CT scan

computed tomography (CT scan)

Device

Subjects will undergo cone beam breast CT scan

Other names: CT scan

Primary outcomes

Correlation between mammography and breast CT on lesion detection

Time frame: 2 years

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.

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Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 22, 2010
Registry last updated: Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed