Molecular Breast Imaging in Screening Breast Cancer

Chang Gung Medical Foundation

Status: Completed

Conditions: Breast Cancer

Treatments: Diagnostic Test: Breast ultrasound; Diagnostic Test: Molecular breast imaging; Diagnostic Test: Mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT03082456

CMRPG2E0341

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: Female

Ages: 45 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female patients undergoing myocardial perfusion imaging will be eligible if they sign the informed consent.

Exclusion criteria

• They are unable to understand and sign the consent form
• They are physically unable to sit upright and still for 20 minutes.
• They have undergone breast surgery or breast biopsy within the last 12 months.
• They have had trauma to the breast tissue or undergone radiation treatment to the breast within the last 12 months.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

Three breast screening modalities

Other group

Description:

Subjects who have had mammography less than two years ago will receive MBI and breast ultrasound only. Other participants will receive three interventions including molecular breast imaging, mammography and breast ultrasound. The interval between each examination will be less than 6 months.

Treatment:

Diagnostic Test: Mammography

Diagnostic Test: Molecular breast imaging

Diagnostic Test: Breast ultrasound