Comparison Study of Breast Computed Tomography (CT) With Magnetic Resonance Imaging (MRI)

NCT00957099 | Completed

• 1 other identifier: IRB00014357
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Lay Summary After patients are diagnosed with breast cancer, they undergo breast magnetic resonance (MR) imaging to determine if the cancer is located in more than one place in the breast. Breast MR imaging is a good option for this test because it has very high sensitivity (catches almost all breast tumors). However, breast MR is slow: it takes about two minutes to acquire one image, and is very low resolution. The points that make up the breast MR image are around 1 to 3 mm in size. Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. As opposed to breast MR, breast CT is very fast. An image can be taken in 10 seconds, and has very high resolution. The points in the breast CT image are only 0.14 mm in size. The investigators propose to use breast CT instead of breast MR imaging to determine if the patient's breast cancer is located in more than one place. This is the first time anybody has proposed to use breast CT for this, so the investigators aim to test the feasibility of the idea with only 6 patients. Since the patients will undergo breast MR as part of the standard of care, the investigators will be able to compare the breast CT images to the current standard, breast MR. This work will lay a foundation for performing this very important test before breast cancer treatment planning with a new, fast, high resolution imaging method, breast CT.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of staging accuracy

  After biopsy

Study Arms (1)

Imaging

Women diagnosed with breast cancer having pre-treatment MRI for spread of disease

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is women who have been diagnosed with breast cancer and have undergone breast MR imaging for detection of multifocal and/or multicentric tumors before undergoing treatment.

You may qualify if:

• Women with suspected or confirmed pregnancy
• Women who have had bilateral mastectomy
• Women who are very frail and unable to cooperate
• Women who cannot give informed consent
• Male subjects
• Women with implants

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital Breast Imaging Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ioannis Sechopoulos, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology and Imaging Sciences

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (1)