Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
Condition: Breast Neoplasms; Breast Diseases; Breast Fibroadenoma; Breast Cancer
MeSH terms: Breast Neoplasms; Fibroadenoma; Breast Diseases
Study type: Interventional
Phase: Early Phase 1

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).
    

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.
    

Intervention name(s): Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)
Intervention type(s): Drug
Intervention description(s): To test the diagnostic effectiveness of an abbreviated MRI to a full MRI in the evaluation of breast lesions using Dotarem
Other intervention name(s): Abbreviated MRI; Abbreviated MRI with Dotarem; Dotarem
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breast; Breast Cancer; Invasive Ductal Cancer; Ductal Carcinoma in situ; Breast Neoplasm; Fibroadenoma