Breast CancerNCT03082456
Molecular Breast Imaging in Screening Breast Cancer
A study testing Molecular breast imaging, Mammography and Breast ultrasound in people with Breast Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Molecular breast imaging, Mammography and Breast ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2015to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients undergoing myocardial perfusion imaging will be eligible if they sign the informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Molecular breast imaging, Mammography, Breast ultrasound
- Keywords
- molecular breast imaging, MBI, breast cancer, mammography, sonography, recall rate, diagnostic accuracy, breast echo, female population
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular breast imagingDiagnostic test
Also called MBI
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.
MammographyDiagnostic test
Also called Mammogram
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.
Breast ultrasoundDiagnostic test
Also called Breast sonography, Breast echo
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.
| Study group | Role | What they receive |
|---|---|---|
| Three breast screening modalities | Other | 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. Receives: Diagnostic Test: Molecular breast imaging; Diagnostic Test: Mammography; Diagnostic Test: Breast ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall rate
The frequency with which a radiologist or physician interprets findings of an examination as positive
Measured: 6 months
Secondary outcomes (1)
Diagnostic efficacy
The sensitivity, specificity, positive predictive value and negative predictive value of each imaging modality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Jun 2015
- Primary completion31 Dec 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082456
- Sponsor's protocol ID
- CMRPG2E0341
- Status last verified
- Jan 2017
- First submitted
- 1 Mar 2017
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Breast Imaging in Screening Breast Cancer
- ClinicalTrials.gov ID
- NCT03082456
- Acronym / sponsor ID
- CMRPG2E0341
- Conditions
- Breast Cancer
- Keywords
- molecular breast imaging, MBI, breast cancer, mammography, sonography, recall rate, diagnostic accuracy, breast echo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three breast screening modalities | Other | Diagnostic Test: Molecular breast imaging, Diagnostic Test: Mammography, Diagnostic Test: Breast ultrasoundSubjects 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. |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients undergoing myocardial perfusion imaging will be eligible if they sign the informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular breast imagingAlso: MBIMolecular 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. | Diagnostic test | Three breast screening modalities |
| MammographyAlso: MammogramDuring 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. | Diagnostic test | Three breast screening modalities |
| Breast ultrasoundAlso: Breast sonography, Breast echoUltrasound investigation of breast is performed by members of breast cancer team. If abnormality is found by the procedure, biopsy will not be performed directly. | Diagnostic test | Three breast screening modalities |
Primary outcome
Recall rate
Time frame: 6 months
The frequency with which a radiologist or physician interprets findings of an examination as positive
1 secondary outcome
Diagnostic efficacy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular breast imaging, Mammography and Breast ultrasound in people with Breast Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.