Low-dose Imaging Technique (LITE)

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Low-dose Imaging

• 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

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-17
• Study Start: 2020-08-24
• Primary Completion: 2020-08-24
• Study Completion: 2020-08-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-dose Imaging	Low-dose Imaging	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.

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.