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Molecular Breast Imaging in the Preoperative Evaluation of Women With Biopsy Proven Breast Cancer

25 Years
Not Enrolling
Breast Cancer

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Trial Information

Molecular Breast Imaging in the Preoperative Evaluation of Women With Biopsy Proven Breast Cancer

The sensitivity of conventional mammography for evaluation of extent of disease, detection
of multifocal breast cancers and contralateral breast cancers is poor. Molecular Breast
Imaging (MBI) is a new nuclear medicine technique that permits the breast to be imaged in a
manner similar to mammography, utilizing a Cadmium-Zinc-Telluride (CZT) gamma camera. We
have developed the first dual-head MBI system in the world and preliminary results from this
system indicate a high sensitivity (~90%) for the detection of breast cancers < 10mm.

The AIM of this study is to determine the sensitivity of MBI relative to mammography in the
preoperative evaluation of the extent of disease in the ipsilateral and contralateral
breasts in women with biopsy-proven breast cancer. We will test the HYPOTHESIS that MBI is
more sensitive than mammography for preoperative evaluation and surgical planning.

The study will comprise 120 women with biopsy-proven breast cancer prior to surgery. All
patients will have a diagnostic mammogram and an MBI study prior to operation. At the time
of operation the pathologic findings will be correlated with both the mammogram and the MBI

This study will demonstrate the use of MBI in three aspects of breast cancer diagnosis: 1)
detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2)
detection of contralateral breast cancer, and 3) correlation of index tumor size on MBI with
pathologic size. These results may justify a role for MBI in the routine pre-operative
evaluation of breast cancer patients.

Inclusion Criteria:

- Women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in

Exclusion Criteria:

- Unable to understand and sign the consent form

- Pregnant or lactating

- Physically unable to sit upright and still for 40 minutes

- Currently receiving neoadjuvant chemotherapy or hormonal therapy

- Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor

- Previous mastectomy

- Previous excisional biopsy of the index breast cancer

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The gold standard for assessing MBI will be tissue pathology. Using pathology as the gold standard, we will compare the sensitivity of MBI to that of mammography in the evaluation of this patient population.

Outcome Time Frame:

At surgery

Safety Issue:


Principal Investigator

Michael K O'Connor, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

February 2011

Related Keywords:

  • Breast Cancer
  • molecular breast imaging
  • breast cancer
  • mammography
  • Breast Neoplasms



Mayo ClinicRochester, Minnesota  55905