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Patients selected for breast-conserving surgery based on conventional radiological methods, following the criteria recommended by the Norwegian Breast Cancer Group

Toril Rabben, MD DDS PhD

The purpose of this prospective observational study is to evaluate the impact of preoperative breast MRI in patients with breast cancer selected for breast- conserving surgery. MRI is a more sensitive radiological modality than mammography and ultrasonography. Patients with small breast cancers are, based on conventional modalities, selected for breast-conserving surgery. If preoperative breast MRI reveal additional lesions in the breasts, and malignancy is confirmed histopathologically, this finding leads to a change of surgical method to mastectomy.

The aim of the study is to evaluate the impact of preoperative breast MRI on primary surgical treatment in a highly specialized multidisciplinary breast cancer clinic. The clinic serves a population of 237.000. The diagnostic tools routinely used are conventional mammography, ultrasound with core needle biopsy, and clinical examination including palpation of breast and axillary nodes. If indicated, the examination includes ultrasound examination and fine needle biopsy of axillary glands. We offer all patients selected for breast-conserving surgery preoperative breast MRI.

We include consecutively breast cancer lesions in women aged 35-75 in a prospective study, collecting data from January 2009 to December 2010. The patients are all selected for breast-conserving surgery based on the criteria recommended by the Norwegian Breast Cancer Group. That is, tumor ≤ 4 cm, or acceptable tumor:breast ratio, and age \> 35. Multifocal lesions, defined as more than one tumor \> 1 cm apart, size of tumor \> 4 cm, or a large tumor:breast ratio, extensive ductal carcinoma in situ (DCIS), or known genetic disposition for breast cancer, indicates mastectomy according to these criterias. In addition, when postoperative radiation therapy is contraindicated, mastectomy is indicated. If the patients fill the criteria for breast-conserving surgery, they are offered preoperative breast MRI and included in the study. Patients who either choose mastectomy, or does not get a breast MRI for technical reasons, are excluded from the study. Two experienced breast radiologists evaluate the breast MRIs, and three experienced breast radiologists study the mammographies and perform the ultrasound examinations and biopsies. All additional MRI findings are examined by ultrasound-guided biopsy and given a histological diagnose before it influence the surgical method.

A formal application has been presented to the regional ethical commitee. Since this is an observational study of established practice, the commitee replied that approval was not required.

The Impact of Preoperative Breast MRI in Patients With Breast Cancer Selected for Breast Conserving Surgery

The Impact of Preoperative Breast MRI in Newly Diagnosed Breast Cancer. A Prospective Study of Treatment Outcome in Patients Selected for Breast Conserving Surgery in a Norwegian Multidisciplinary Breast Cancer Clinic.

Nordlandssykehuset HF

Toril Rabben/MD DDS PhD Associate professor

Desiree Doncals, MD

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

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.

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

Evaluation of Breast Magnetic Resonance Imaging (MRI) Impact on Mastectomy Rate at Summa Akron City Hospital

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.

Study title	NCT ID	Conditions	Eligibility	Organization
The Impact of Preoperative Breast MRI in Patients With Breast Cancer Selected for Breast Conserving Surgery	NCT01391806	Breast Cancer	35 Years - 75 Years	Nordlandssykehuset HF
Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates	NCT01166581	Early Stage Bre...	18 Years - 85 Years	Summa Health System
Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates	NCT01166581	Early Stage Bre...	18 Years - 85 Years	Summa Health System
Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates	NCT01166581	Early Stage Bre...	18 Years - 85 Years	Summa Health System
Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates	NCT01166581	Early Stage Bre...	18 Years - 85 Years	Summa Health System
The Impact of Preoperative Breast MRI in Patients With Breast Cancer Selected for Breast Conserving Surgery	NCT01391806	Breast Cancer	35 Years - 75 Years	Nordlandssykehuset HF

Spots Global Cancer Trial Database for preoperative breast mri