NCT04350957

Low-dose Imaging Technique (LITE)

Low-dose Imaging Technique (LITE) MRI Gadavist® (Gadobutrol)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Low-dose Imaging	We are comparing MRI image quality for diagnostic purposes. We hope to learn whether using a lesser dose (25%) of the FDA approved contrast agent, Gadavist®, is just as effective as a standard or full dose (100%) of the same contrast in a breast MRI. This research is being done because breast MRI's have repeatedly been shown to represent the most reliable imaging method for breast cancer screening and diagnosis, regardless of personal risk for breast cancer and radiographic breast density. However, there are growing concerns about getting frequent breast MRI examinations due to the deposition of gadolinium, a metal ion that is found in all breast MRI contrast agents. The FDA states that this deposition and retention is not known to have any long term side effects on patient. However, the researchers at the University of Chicago Medicine would like to further investigate this using a lesser dose of contrast agent than the recommended dose for breast MRI examinations.

Timeline

• Start date: 2020-08-24
• Primary completion: 2020-08-24
• Completion: 2020-08-24
• First posted: 2020-04-17
• Last updated: 2023-04-26