Clinical trial NCT03082456: Molecular Breast Imaging in Screening Breast Cancer
Official title: Molecular Breast Imaging in Screening Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: molecular breast imaging
MBI
breast cancer
mammography
sonography
recall rate
diagnostic accuracy
breast echo
female population
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 164
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recall rate
timeFrame: 6 months
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: TzuPei Su
Study officials:
References: