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

NCT ID: NCT01166581

Last Updated: 2015-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Early Stage Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Summa Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Desiree Doncals, MD

Role: PRINCIPAL_INVESTIGATOR

Summa Health System

Locations

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Summa Akron City Hospital

Akron, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17433681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19969136 (View on PubMed)

Other Identifiers

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Doncals Breast MRI study

Identifier Type: -

Identifier Source: org_study_id

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