Abbreviated MRI using Dotarem for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+3 MoreAbbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine) - Drug
Eligibility
18 - 80
Female
What conditions do you have?
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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 Fibroadenoma
  • Breast Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: one year

one year
Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol

Trial Safety

Safety Progress

1 of 3

Side Effects for

Between Dotarem and Xenetix 350 Injection
1%Dizziness
1%Headache
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01254552) in the Between Dotarem and Xenetix 350 Injection ARM group. Side effects include: Dizziness with 1%, Headache with 1%.

Trial Design

1 Treatment Group

Abbreviated MRI using Dotarem
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Abbreviated MRI using Dotarem · No Placebo Group · Phase < 1

Abbreviated MRI using Dotarem
Drug
Experimental Group · 1 Intervention: Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

GuerbetIndustry Sponsor
62 Previous Clinical Trials
93,026 Total Patients Enrolled
University of ChicagoLead Sponsor
923 Previous Clinical Trials
743,278 Total Patients Enrolled
23 Trials studying Breast Cancer
4,710 Patients Enrolled for Breast Cancer
Hiroyuki Abe, MDPrincipal InvestigatorUniversity of Chicago Medicine
Deepa Sheth, MDPrincipal InvestigatorUniversity of Chicago Medicine
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Breast Cancer
50 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18 - 80 · Female Participants · 2 Total Inclusion Criteria

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References