Comparison Study of Breast Computed Tomography (CT) With Magnetic Resonance Imaging (MRI)
NCT ID: NCT00957099
Last Updated: 2013-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2 participants
OBSERVATIONAL
2009-06-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Imaging
Women diagnosed with breast cancer having pre-treatment MRI for spread of disease
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ioannis Sechopoulos, Ph.D.
Assistant Professor of Radiology and Imaging Sciences
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ioannis Sechopoulos, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University Hospital Breast Imaging Center
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00014357
Identifier Type: -
Identifier Source: org_study_id