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NCT01166581 Clinical Trial

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

Early Stage Breast Cancer Clinical Trial

Official title:
Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01166581
Other study ID # Doncals Breast MRI study
Secondary ID
Status Terminated
Phase N/A
First received July 19, 2010
Last updated February 3, 2015
Start date July 2010
Est. completion date January 2015

Study information
Verified date February 2015
Source Summa Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

Description:

Early stage breast cancer cases between 2006 and 2009 will be identified by the Summa Akron City Hospital cancer registry. The cases will be reviewed and abstracted. The abstracted data will include results of physical breast examinations, mammograms, sonograms, breast MRI reports, biopsy procedure notes and pathology reports to illustrate the clinical stage. Definitive surgical pathology reports will be included in the abstracted data to demonstrate the final pathologic stage of the breast cancer.

A database will be developed to capture the abstracted data. Outcomes will be determined based on final pathology reports.

Recruitment information / eligibility
Status Terminated
Enrollment 300
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- early stage breast cancer between 2006-2009

- preoperative MRI

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Summa Akron City Hospital Akron Ohio

Sponsors (1)
Lead Sponsor Collaborator
Summa Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Epub 2007 Apr 12. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer 2006-2009 No
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