Molecular Breast Imaging in Screening Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The molecular breast imaging (MBI) is a potential modality to screen breast cancer. In this
      study, we compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and
      breast sonography, and aim to determine best ways of breast cancer screening.
    

Detailed description: 
      Keywords: molecular breast imaging, MBI, breast cancer, mammography, sonography

        1. Background: In breast cancer screening, the sensitivity of mammography is about 71-96 %,
           but the sensitivity decreases in the three following groups: (1) under 50 years old; (2)
           dense breast parenchyma; (3) higher risk of breast cancer. The Health and Welfare
           Ministry data in recent 2 years showed Taiwanese women accepted mammography for
           screening in the ratio of only about 36%, representing many missed opportunities for
           early detection. One reason to reject mammography may be the discomfort caused by
           compression. To solve the above mammography possible weakness, other screening methods
           came into being, such as molecular breast imaging (MBI) of nuclear medicine. Radiotracer
           of Tc-99m sestamibi was found for targeting breast tumor 20 years ago, and approved by
           the FDA in 1997. However, the application is limited due to the suboptimal scanning
           camera design. Ten years later, the Mayo Clinics developed MBI technology, using
           small-sized semiconductor detectors. Then it become possible that the nuclear
           technologist have patient's breast tissue fit the detector in almost the same fashion of
           mammography without heavy compression.

        2. Objective: The aim of this study is to evaluate the recall rate and diagnostic accuracy
           of MBI, mammography and breast echo, for female population.

        3. Study design: Female patients referred to Nuclear Medicine Department for myocardial
           perfusion scan will be recruited in this study. It is because that MBI and myocardial
           perfusion scan share the same radiotracer. Then MBI will become additional scanning
           only. About 1800 female subjects will involve, and further mammography and/or breast
           sonography will be arranged within 6 months after MBI. Participants will be encouraged
           to receive mammography every 2 years and telephone survey. We hope that this study will
           help us to compare and evaluate the recall rate/diagnostic efficiency of MBI,
           mammography and breast sonography, and to determine best ways of breast cancer
           screening.
    

Intervention name(s): Molecular breast imaging; Mammography; Breast ultrasound
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Molecular breast imaging will be performed at 5-10 minutes after intravenous injection of 15-20 millicurie (mCi) Tc-99m sestamibi. Both craniocaudal (CC) view and mediolateral oblique (MLO) images of the breast are taken.; During the procedure, the breast is compressed using a dedicated mammography unit. Parallel-plate compression evens out the thickness of breast tissue to increase image quality by reducing the thickness of tissue that x-rays must penetrate, decreasing the amount of scattered radiation, reducing the required radiation dose, and holding the breast still (preventing motion blur). Both craniocaudal (CC) view and mediolateral oblique (MLO) images of the breast are taken.; Ultrasound investigation of breast is performed by members of breast cancer team. If abnormality is found by the procedure, biopsy will not be performed directly.
Other intervention name(s): MBI; Mammogram; Breast sonography; Breast echo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: molecular breast imaging; MBI; breast cancer; mammography; sonography; recall rate; diagnostic accuracy; breast echo; female population