Low-dose Imaging Technique (LITE)
- Conditions
- Breast Cancer
- Registration Number
- NCT04350957
- Lead Sponsor
- University of Chicago
- Brief Summary
The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.
Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Women between the ages of 18-80
- Women with a suspected or biopsy proven enhancing lesion
- Women with a history of adverse reactions to contrast media
- Women with GFR below 30 mL/min/1.73m2
- Women who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Low-dose Lesion Enhancement Through study completion, an average of 1 year Readers will initially be provided with two MIP images and asked to decide on presence or absence of significant enhancement. The two MIP images will be created from the low dose images and the standard dose images respectively.
- Secondary Outcome Measures
Name Time Method