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Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)

NCT04341129 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-05

No results posted yet for this study

Summary

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. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast 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 with ultrafast imaging using Dotarem® (Gadoterate Meglumine).

Conditions

  • Breast Neoplasms
  • Breast Diseases
  • Breast Fibroadenoma
  • Breast Cancer

Interventions

DRUG

Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)

To test the diagnostic effectiveness of an abbreviated MRI to a full MRI in the evaluation of breast lesions using Dotarem

Sponsors & Collaborators

  • Guerbet

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Hiroyuki Abe, MD · University of Chicago Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04341129 on ClinicalTrials.gov