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

This study has been completed.
Sponsor:
Information provided by:
Nordlandssykehuset HF
ClinicalTrials.gov Identifier:
NCT01391806
First received: July 11, 2011
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Nordlandssykehuset HF:

Primary Outcome Measures:
  • Change of surgical method after preoperative breast MRI in breast cancer [ Time Frame: Two years of data collection ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer
Patients selected for breast-conserving surgery based on conventional radiological methods, following the criteria recommended by the Norwegian Breast Cancer Group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients are selected from screening or they are referred to the Breast Diagnostic Clinic for clinical symptoms. The clinic serves a population of 237.000 in Nordland county, Norway. Patients selected for breast-conserving surgery based on conventional radiological examination, that is bilateral mammography and ultrasonography with biopsy, are consecutively included in the study and offered preoperative breast MRI.

Criteria

Inclusion Criteria:

  • Patients ≥ 35 years and ≤ 75 years
  • Indication for breast-conserving surgery according to criteria recommended by the Norwegian Breast Cancer Group:
  • Tumor < 4 cm and acceptable tumor:breast ratio
  • Tumor not infiltrating skin or pectoral fascia
  • No multifocality (that is 2 foci or more, > 1 cm apart)

Exclusion Criteria:

  • Patient choose mastectomy
  • Technical problems with the MR machine
  • Pacemaker
  • Anxiety/claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391806

Locations
Norway
Breast Diagnostic Centre, Dep. of Surgery, Nordlandssykehuset Bodø
Bodø, Norway, 8092
Sponsors and Collaborators
Nordlandssykehuset HF
Investigators
Principal Investigator: Toril Rabben, MD DDS PhD Dep. of Surgery, Nordlandssykehuset Bodø, 8092 Bodø, Norway
  More Information

No publications provided

Responsible Party: Toril Rabben/MD DDS PhD Associate professor, Dep. of Surgery, Nordlandssykehuset Bodø, 8092 Bodø and Faculty of Health Sciences, University of Tromsø, 9037 Tromsø, Norway
ClinicalTrials.gov Identifier: NCT01391806     History of Changes
Other Study ID Numbers: PreopMR 2011
Study First Received: July 11, 2011
Last Updated: July 11, 2011
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Nordlandssykehuset HF:
Breast cancer
Preoperative breast MRI
Breast-conserving surgery
Mastectomy
Prospective study

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

ClinicalTrials.gov processed this record on October 20, 2014