Clinical trial NCT00957099: Comparison Study of Breast Computed Tomography (CT) With Magnetic Resonance Imaging (MRI)
Official title: A Comparison Study of Contrast Enhanced Breast CT With MRI On Known Malignancies For Detection of Multifocal/Multicentric Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 2
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: See above

Eligibility criteria: 3.1 Eligibility Criteria All subjects will be women at least 35 years of age that have been diagnosed with breast cancer and have undergone breast MR imaging for detection of multifocal/multicentric disease.

3.2 Ineligibility Criteria

* Subject does not meet any of the inclusion criteria
* 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

Primary outcomes:
measure: Comparison of staging accuracy
timeFrame: After biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Breast Imaging Center
state: Georgia
Study officials:
affiliation: Emory University
name: Ioannis Sechopoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: