Clinical trial NCT01166581: Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates
Official title: Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Early Stage Breast Cancer
Keywords: early stage breast cancer
preoperative breast MRI
mastectomy
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2010-07-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: early stage breast cancer cases between 2006-2009

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: 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.
timeFrame: from 2006-2009
Secondary outcomes:
measure: Correlate the breast MRI findings with the final pathology results to determine if the breast MRI clinically upstaged the cancer
timeFrame: 2006-2009
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Akron City Hospital
state: Ohio
Study officials:
affiliation: Summa Health System
name: Desiree Doncals, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.breast.2007.02.004. Epub 2007 Apr 12.
citation: 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.