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Molecular Breast Imaging in Screening Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Molecular breast imaging
Mammography
Breast ultrasound
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring molecular breast imaging, MBI, breast cancer, mammography, sonography, recall rate, diagnostic accuracy, breast echo, female population

Eligibility Criteria

45 Years - 69 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • TzuPei Su

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Three breast screening modalities

Arm 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.

Outcomes

Primary Outcome Measures

Recall rate
The frequency with which a radiologist or physician interprets findings of an examination as positive

Secondary Outcome Measures

Diagnostic efficacy
The sensitivity, specificity, positive predictive value and negative predictive value of each imaging modality

Full Information

First Posted
March 1, 2017
Last Updated
May 11, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03082456
Brief Title
Molecular Breast Imaging in Screening Breast Cancer
Official Title
Molecular Breast Imaging in Screening Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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. Objective: The aim of this study is to evaluate the recall rate and diagnostic accuracy of MBI, mammography and breast echo, for female population. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
molecular breast imaging, MBI, breast cancer, mammography, sonography, recall rate, diagnostic accuracy, breast echo, female population

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three breast screening modalities
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Molecular breast imaging
Other Intervention Name(s)
MBI
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Mammography
Other Intervention Name(s)
Mammogram
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Breast ultrasound
Other Intervention Name(s)
Breast sonography, Breast echo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recall rate
Description
The frequency with which a radiologist or physician interprets findings of an examination as positive
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Diagnostic efficacy
Description
The sensitivity, specificity, positive predictive value and negative predictive value of each imaging modality
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
TzuPei Su
City
Keelung
ZIP/Postal Code
204
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Molecular Breast Imaging in Screening Breast Cancer

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