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

Terminated

• Conditions: Early Stage Breast Cancer

• Registration Number: NCT01166581
• Lead Sponsor: Summa Health System

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

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	from 2006-2009	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.

Secondary Outcome Measures

Name	Time	Method
Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer	2006-2009

Trial Locations

Locations (1)

Summa Akron City Hospital; 🇺🇸 Akron, Ohio, United States