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

This study is currently recruiting participants.
Verified April 2012 by Summa Health System
Sponsor:
Information provided by (Responsible Party):
Summa Health System
ClinicalTrials.gov Identifier:
NCT01166581
First received: July 19, 2010
Last updated: May 30, 2013
Last verified: April 2012
History of Changes
  Purpose

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
Early Stage Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer [ Time Frame: 2006-2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders 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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166581

Contacts
Contact: Joyce Neading, RHIT, CTR 330.375.4221 neadinja@summahealth.org
Contact: Heidi Eve-Cahoon, MSN, CNP 330.375.7082 cahoonh@summahealth.org

Locations
United States, Ohio
Summa Akron City Hospital Recruiting
Akron, Ohio, United States, 44304
Contact: Donna L Bechtel, BME, CIM            
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Desiree Doncals, MD Summa Health System
  More Information

Publications:

Responsible Party: Summa Health System
ClinicalTrials.gov Identifier: NCT01166581     History of Changes
Other Study ID Numbers: Doncals Breast MRI study
Study First Received: July 19, 2010
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
early stage breast cancer
preoperative breast MRI
mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013