Low-dose Imaging Technique (LITE)

The University of Chicago

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Diagnostic Test: Low-dose Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04350957

IRB20-0528

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women between the ages of 18-80
• Women with a suspected or biopsy proven enhancing lesion

Exclusion criteria

• 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Low-dose Imaging

Experimental group

Description:

Enrolled patients will undergo two separate dynamic contrast-enhanced MRI's, one with 25% of the contrast dose and one with 100% of the contrast dose recommended by weight. During the first visit, the subject will receive 25% of the standard dose of contrast media 0.1 mM/kg will be administered at 2 mls/second followed by the acquisition of a series of DCE images. On the second visit, the subject will receive 100% of the contrast media followed by the same imaging protocol as the one subsequent to the first contrast administration.

Treatment:

Diagnostic Test: Low-dose Imaging