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

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ClinicalTrials.gov Identifier: NCT04341129
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
University of Chicago

Brief 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).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Diseases Breast Fibroadenoma Breast Cancer Drug: Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine) Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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:
  • Abbreviated MRI
  • Abbreviated MRI with Dotarem
  • Dotarem




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341129


Contacts
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Contact: Brenda Clinical Research Coordinator 7737021089 BGonzales@radiology.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Brenda Gonzales    773-702-1089    BGonzales@radiology.bsd.uchicago.edu   
Contact: Deepa Sheth, MD    7738344807    DSheth@radiology.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Guerbet
Investigators
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Principal Investigator: Deepa Sheth, MD University of Chicago Medicine
Additional Information:
Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04341129    
Other Study ID Numbers: IRB19-2074
I002672 ( Other Grant/Funding Number: Guerbet )
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: the data will be available indefinitely
Access Criteria: Any researcher who wishes to access the data

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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
Keywords provided by University of Chicago:
Breast
Breast Cancer
Invasive Ductal Cancer
Ductal Carcinoma in situ
Breast Neoplasm
Fibroadenoma
Additional relevant MeSH terms:
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Breast Neoplasms
Fibroadenoma
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action