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

NCT01391806 | Completed

• 1 other identifier: PreopMR 2011
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Preoperative breast MRI; Breast-conserving surgery; Mastectomy; Prospective study

Outcome Measures

Primary Outcomes (1)

• Change of surgical method after preoperative breast MRI in breast cancer

  Two years of data collection

Study Arms (1)

Breast cancer

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

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Patient choose mastectomy
• Technical problems with the MR machine
• Pacemaker
• Anxiety/claustrophobia

Sponsors & Collaborators

• Nordlandssykehuset HF: lead

Study Sites (1)

Breast Diagnostic Centre, Dep. of Surgery, Nordlandssykehuset Bodø

Bodø, 8092, Norway

Location

Related Links

• Sponsor´s web-site

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Toril Rabben, MD DDS PhD

  Dep. of Surgery, Nordlandssykehuset Bodø, 8092 Bodø, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 12, 2011

Record last verified: 2009-01

Locations

NO (1)