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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341129
• Other study ID #: IRB19-2074
• Secondary ID: I002672
• Status: Completed
• Phase: Early Phase 1
• Start date: July 13, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Guerbet

Country where clinical trial is conducted

United States, 

References & Publications (17)

Abe H, Mori N, Tsuchiya K, Schacht DV, Pineda FD, Jiang Y, Karczmar GS. Kinetic Analysis of Benign and Malignant Breast Lesions With Ultrafast Dynamic Contrast-Enhanced MRI: Comparison With Standard Kinetic Assessment. AJR Am J Roentgenol. 2016 Nov;207(5):1159-1166. doi: 10.2214/AJR.15.15957. Epub 2016 Aug 17. — View Citation

Feig S. Cost-effectiveness of mammography, MRI, and ultrasonography for breast cancer screening. Radiol Clin North Am. 2010 Sep;48(5):879-91. doi: 10.1016/j.rcl.2010.06.002. — View Citation

Harvey SC, Di Carlo PA, Lee B, Obadina E, Sippo D, Mullen L. An Abbreviated Protocol for High-Risk Screening Breast MRI Saves Time and Resources. J Am Coll Radiol. 2016 Apr;13(4):374-80. doi: 10.1016/j.jacr.2015.08.015. Epub 2015 Oct 27. — View Citation

Kuhl C. The current status of breast MR imaging. Part I. Choice of technique, image interpretation, diagnostic accuracy, and transfer to clinical practice. Radiology. 2007 Aug;244(2):356-78. doi: 10.1148/radiol.2442051620. — View Citation

Kuhl CK, Schild HH, Morakkabati N. Dynamic bilateral contrast-enhanced MR imaging of the breast: trade-off between spatial and temporal resolution. Radiology. 2005 Sep;236(3):789-800. doi: 10.1148/radiol.2363040811. — View Citation

Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. J Clin Oncol. 2014 Aug 1;32(22):2304-10. doi: 10.1200/JCO.2013.52.5386. Epub 2014 Jun 23. — View Citation

Kuhl CK. Current status of breast MR imaging. Part 2. Clinical applications. Radiology. 2007 Sep;244(3):672-91. doi: 10.1148/radiol.2443051661. — View Citation

Lee CH, Dershaw DD, Kopans D, Evans P, Monsees B, Monticciolo D, Brenner RJ, Bassett L, Berg W, Feig S, Hendrick E, Mendelson E, D'Orsi C, Sickles E, Burhenne LW. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Am Coll Radiol. 2010 Jan;7(1):18-27. doi: 10.1016/j.jacr.2009.09.022. — View Citation

Mango VL, Morris EA, David Dershaw D, Abramson A, Fry C, Moskowitz CS, Hughes M, Kaplan J, Jochelson MS. Abbreviated protocol for breast MRI: are multiple sequences needed for cancer detection? Eur J Radiol. 2015 Jan;84(1):65-70. doi: 10.1016/j.ejrad.2014.10.004. Epub 2014 Oct 16. — View Citation

Mann RM, Mus RD, van Zelst J, Geppert C, Karssemeijer N, Platel B. A novel approach to contrast-enhanced breast magnetic resonance imaging for screening: high-resolution ultrafast dynamic imaging. Invest Radiol. 2014 Sep;49(9):579-85. doi: 10.1097/RLI.0000000000000057. — View Citation

Moore SG, Shenoy PJ, Fanucchi L, Tumeh JW, Flowers CR. Cost-effectiveness of MRI compared to mammography for breast cancer screening in a high risk population. BMC Health Serv Res. 2009 Jan 13;9:9. doi: 10.1186/1472-6963-9-9. — View Citation

Nelson HD, O'Meara ES, Kerlikowske K, Balch S, Miglioretti D. Factors Associated With Rates of False-Positive and False-Negative Results From Digital Mammography Screening: An Analysis of Registry Data. Ann Intern Med. 2016 Feb 16;164(4):226-35. doi: 10.7326/M15-0971. Epub 2016 Jan 12. — View Citation

Pineda FD, Medved M, Wang S, Fan X, Schacht DV, Sennett C, Oto A, Newstead GM, Abe H, Karczmar GS. Ultrafast Bilateral DCE-MRI of the Breast with Conventional Fourier Sampling: Preliminary Evaluation of Semi-quantitative Analysis. Acad Radiol. 2016 Sep;23(9):1137-44. doi: 10.1016/j.acra.2016.04.008. Epub 2016 Jun 6. — View Citation

Saslow D, Boetes C, Burke W, Harms S, Leach MO, Lehman CD, Morris E, Pisano E, Schnall M, Sener S, Smith RA, Warner E, Yaffe M, Andrews KS, Russell CA; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007 Mar-Apr;57(2):75-89. doi: 10.3322/canjclin.57.2.75. Erratum In: CA Cancer J Clin. 2007 May-Jun;57(3):185. — View Citation

Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1. — View Citation

Tsao J, Kozerke S. MRI temporal acceleration techniques. J Magn Reson Imaging. 2012 Sep;36(3):543-60. doi: 10.1002/jmri.23640. — View Citation

Veltman J, Stoutjesdijk M, Mann R, Huisman HJ, Barentsz JO, Blickman JG, Boetes C. Contrast-enhanced magnetic resonance imaging of the breast: the value of pharmacokinetic parameters derived from fast dynamic imaging during initial enhancement in classifying lesions. Eur Radiol. 2008 Jun;18(6):1123-33. doi: 10.1007/s00330-008-0870-8. Epub 2008 Feb 13. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the diagnostic accuracy of dynamic contrast-enhanced breast MRIs performed with an abbreviated protocol versus a full protocol	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

External Links

•   American Cancer Society website. Cancer facts and figures 2016
•   American College of Radiology website. ACR Appropriateness Criteria: breast cancer screening. Date of origin 2012. Last review date 2016.
•   National Cancer Institute website. SEER stat fact sheets:female breast cancer