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Contrast Agent

Abbreviated MRI using Dotarem for Breast Cancer

Phase < 1
Waitlist Available
Led By Deepa Sheth, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This trial is investigating whether using a shorter, cheaper MRI protocol can still provide accurate diagnosis of breast lesions, as well as valuable information about their function.

Eligible Conditions
  • Breast Cancer
  • Breast Disease
  • Breast Fibroadenoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol

Side effects data

From 2016 Phase 4 trial • 351 Patients • NCT01254552
1%
Headache
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Between Dotarem and Xenetix 350 Injection
During Xenetix 350 Injection
After Xenetix 350 Injection

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abbreviated MRI using DotaremExperimental Treatment1 Intervention
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. The shorter imaging times achieved with the abbreviated DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol using Dotarem® (Gadoterate Meglumine) by comparing the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadoteric acid
FDA approved

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,800 Total Patients Enrolled
25 Trials studying Breast Cancer
4,709 Patients Enrolled for Breast Cancer
GuerbetIndustry Sponsor
68 Previous Clinical Trials
93,672 Total Patients Enrolled
Deepa Sheth, MDPrincipal InvestigatorUniversity of Chicago Medicine
1 Previous Clinical Trials
1 Trials studying Breast Cancer

Frequently Asked Questions

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~11 spots leftby Apr 2025