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

December 4, 2023 updated by: University of Chicago
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is second to lung cancer as the leading cause of death among women in the United States. Over 40,000 women were estimated to die of breast cancer in 2016. Early detection is key to improved survival, and overall prognosis is directly linked to the stage of disease at the time of diagnosis. The 5-year relative survival rate has increased since the mid 1970's, in part owing to improvements in early breast cancer detection with screening mammography. Screening with mammography is associated with a 16-40% relative reduction in breast cancer mortality among women aged 40-74 years old, and mammography is the most cost-effective method of breast cancer screening. However, cancers can be missed at mammography, particularly in women with dense breasts. Screening with mammography alone may be insufficient in the screening of women who are at high risk of breast cancer. The need for more effective screening strategies to supplement mammography in these groups of women has led to the use of dynamic contrast-enhanced (DCE) breast MRI. Of the available modalities for evaluation of the breast, MRI has been found to have the highest sensitivity for the detection of breast cancer, irrespective of breast density.

On the basis of evidence from nonrandomized trials and observational studies, breast MRI is indicated as a supplement to mammography for patients at high risk with greater than 20% relative lifetime risk. This cohort of women includes those with: a known BRCA1 or BRCA2 genetic mutation, an approximately 20-25% or greater lifetime risk of breast cancer according to risk assessment tools, a strong family history of beast or ovarian cancer, a history of being treated for Hodgkin's disease and certain genetic syndromes (i.e. Li-Fraumeni syndrome, Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome). However, for women at intermediate risk, including those with dense breast tissue, screening MRI in the United States is not cost-effective. The cost-effectiveness of screening breast MRI depends on estimated breast cancer incidence and examination cost. The rationale for limiting supplemental screening breast MRI to those at greatest risk is in part due to its high cost.

Investigators have looked at ways of reducing the cost of breast MRI to improve access to it as a supplement screening method for women who are not necessarily in the highest risk group. One way to achieve the efficiency and rapid throughput found with screening mammography is to shorten screening breast MRI protocols, decrease image acquisition time, and shorten image interpretation time. Study results have suggested that shorter protocols and shorter acquisition times can be achieved with maintenance of diagnostic accuracy comparable to that obtained with conventional MRI protocols. Use of these abbreviated MRI protocols could result in lower cost and faster throughput, increasing availability and providing women with dense breasts or at intermediate risk (lifetime risk, 15-20%) greater access to breast MRI.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women between the ages of 18-80.
  • Women with diagnostic imaging findings highly suspicious for breast cancer (BI-RADS category 4 or 5) or known breast cancer (BI-RADS category 6). Per BI-RADS lexicon, category 4 lesions carry a malignancy risk of 2-95% and category 5 lesions carry a malignancy risk of >95%.

Exclusion Criteria:

  • Women with a history of adverse reactions to contrast media.
  • Women with GFR below 30 mL/min/1.73m².

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abbreviated MRI using Dotarem
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.
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
Other Names:
  • Dotarem
  • Abbreviated MRI
  • Abbreviated MRI with Dotarem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol
Time Frame: one year
The abbreviated protocol will be generated from the full diagnostic protocol. It will comprise of a single unenhanced sequence and a single contrast-enhanced sequence. Subtraction images and a maximum intensity projection (MIP) image will be generated post-examination. The novel kinetic information obtained from the early contrast in combination with morphologic information from a high spatial resolution post-contrast scan, may provide unique dynamic parameters to effectively characterize and diagnose breast lesions on MR imaging.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Guerbet

Investigators

  • Principal Investigator: Hiroyuki Abe, MD, University of Chicago Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB19-2074
  • I002672 (Other Grant/Funding Number: Guerbet)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All study details, including study protocol, statistical analysis plan and informed consent plan, will be made available to all researchers through AURA (Automating University-wide Research Administration) -IRB and our electronic medical record.

IPD Sharing Time Frame

the data will be available indefinitely

IPD Sharing Access Criteria

Any researcher who wishes to access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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