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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ioannis Sechopoulos, Ph.D., Emory University
ClinicalTrials.gov Identifier:
NCT00957099
First received: August 11, 2009
Last updated: September 11, 2013
Last verified: September 2013

August 11, 2009
September 11, 2013
June 2009
September 2011   (final data collection date for primary outcome measure)
Comparison of staging accuracy [ Time Frame: After biopsy ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00957099 on ClinicalTrials.gov Archive Site
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Comparison Study of Breast Computed Tomography (CT) With Magnetic Resonance Imaging (MRI)
A Comparison Study of Contrast Enhanced Breast CT With MRI On Known Malignancies For Detection of Multifocal/Multicentric Disease

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.

See above

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Breast Cancer
Not Provided
Imaging
Women diagnosed with breast cancer having pre-treatment MRI for spread of disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
January 2012
September 2011   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957099
IRB00014357
No
Ioannis Sechopoulos, Ph.D., Emory University
Emory University
Not Provided
Principal Investigator: Ioannis Sechopoulos, PhD Emory University
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP