Use of Molecular Breast Imaging (MBI) to Detect Additional Disease in Women With Breast Cancer Who Are About to go to Surgery

Conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. Initial results with this method have shown it is very good at detecting small breast cancers (~1/4 inch).

The purpose of this study is to see if MBI is a better method than mammography in determining how much cancer is present before a woman goes to surgery.

The study will comprise 120 women with breast cancer who are going to surgery. The investigators hope that this study will demonstrate that MBI will be more accurate in determining how much cancer is present.

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Key information

Conditions

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

Age range

25 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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 results.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

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.

Time frame: At surgery

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Gamma Medica-Ideas

Registry information

Official study title

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

Acronym: MBI

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Oct 21, 2008
Registry last updated: Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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