Role of 3D Tomography in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Role of 3D Tomography in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090687
• Other study ID #: URMC-UMASS
• Secondary ID: 1R21CA134128-01A
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 22, 2010
• Last updated: July 31, 2013
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: July 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan

Device:
• computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan

Locations

Country	Name	City	State
United States	University of Rochester Medical Center, Highland Breast Imaging Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between mammography and breast CT on lesion detection	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.	2 years	Yes