Role of 3D Tomography in Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Device: computed tomography (CT scan)

• Registration Number: NCT01090687
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-22
• Study Start: 2010-03
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-22
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-31
• Last Update Posted: 2013-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I Microcalcifications	computed tomography (CT scan)	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	computed tomography (CT scan)	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.

Primary Outcome Measures

Name	Time	Method
Correlation between mammography and breast CT on lesion detection	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.

Trial Locations

Locations (1)

University of Rochester Medical Center, Highland Breast Imaging Center; 🇺🇸 Rochester, New York, United States