Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates

NCT01166581 | Terminated

• 1 other identifier: Doncals Breast MRI study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is defined as breast tumor size less than 5 cm. The objectives are to:

• Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging
• Determine the results of preoperative breast MRI and the impact on type of surgery performed
• Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or patient decision and if this decision was based on breast MRI findings

Conditions

Early Stage Breast Cancer

Keywords

early stage breast cancer; preoperative breast MRI; mastectomy

Outcome Measures

Primary Outcomes (1)

• The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery than breast conserving surgery in early stage breast cancers at Summa Akron City Hospital.

  Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging Determine the results of preoperative breast MRI and the impact on type of surgery performed Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer.

  from 2006-2009

Secondary Outcomes (1)

• Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer

  2006-2009

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

early stage breast cancer cases between 2006-2009

You may qualify if:

• early stage breast cancer between 2006-2009
• preoperative MRI

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (1)

Summa Akron City Hospital

Akron, Ohio, 44304, United States

Location

Related Publications (2)

• Del Frate C, Borghese L, Cedolini C, Bestagno A, Puglisi F, Isola M, Soldano F, Bazzocchi M. Role of pre-surgical breast MRI in the management of invasive breast carcinoma. Breast. 2007 Oct;16(5):469-81. doi: 10.1016/j.breast.2007.02.004. Epub 2007 Apr 12.

  PMID: 17433681 BACKGROUND

• Ciocchetti JM, Joy N, Staller S, Warmack J, Mann A, Moore JT, Davis-Merritt DK. The effect of magnetic resonance imaging in the workup of breast cancer. Am J Surg. 2009 Dec;198(6):824-8. doi: 10.1016/j.amjsurg.2009.05.029.

  PMID: 19969136 BACKGROUND

Study Officials

• Desiree Doncals, MD

  Summa Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)