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

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ClinicalTrials.gov Identifier: NCT01166581
Recruitment Status : Terminated (Not enough data collected to work with)
First Posted : July 21, 2010
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Early Stage Breast Cancer

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 Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital
Study Start Date : July 2010
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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. [ Time Frame: 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 :
  1. Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer [ Time Frame: 2006-2009 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
early stage breast cancer cases between 2006-2009
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166581


Locations
United States, Ohio
Summa Akron City Hospital
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Desiree Doncals, MD Summa Health System