Molecular Breast Imaging in Screening Breast Cancer
1 other identifier
interventional
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jun 2015
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMay 13, 2020
January 1, 2017
3.6 years
March 1, 2017
May 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recall rate
The frequency with which a radiologist or physician interprets findings of an examination as positive
6 months
Secondary Outcomes (1)
Diagnostic efficacy
6 months
Study Arms (1)
Three breast screening modalities
OTHERSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female patients undergoing myocardial perfusion imaging will be eligible if they sign the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TzuPei Su
Keelung, 204, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2017
First Posted
March 17, 2017
Study Start
June 1, 2015
Primary Completion
December 31, 2018
Study Completion
June 1, 2019
Last Updated
May 13, 2020
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share