DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer, BIRADS 3, BIRADS 4, BIRADS 5

In brief

A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.

Key facts

Study ID

NCT02022579

Run by

American College of Radiology Imaging Network

People needed

100

Starts

2014-01-01

Expected to finish

2019-03-01

Last updated by the study team

2018-10-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent;
• 18 years of age or older;
• Successful completion of breast MR examination with DWI required by protocol;
• Undiagnosed breast lesion (BI-RADS 3, 4, or 5) identified on MRI. The BI-RADS assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.).

You may not qualify if…

• Participants with current or recent history (within 6 months prior to the MRI) of chemotherapy for cancer;
• Neoadjuvant chemotherapy between MRI and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy);
• Pregnant (if a female is of childbearing potential - defined as a pre-menopausal female capable of becoming pregnant - confirmation of pregnancy status per the site's standard of practice should be done prior to MRI);
• Unwilling or not suitable to undergo MRI or use the contrast agent gadolinium.

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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