Breast CancerNCT02777164
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
A study testing MIRA device imaging in people with Breast Cancer, run by Real Imaging Ltd. at 1 site in United States.
Trial summary
The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MIRA device imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Oct 2018
- 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 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are asymptomatic and scheduled to undergo routine screening mammography
- OR
- Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care imaging modalities
- AND
- Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously dense breast tissue (Density C or D)
Who cannot join
- Male by birth.
- Individual is less than 30 and greater than 70 years old.
- Contraindication to bilateral mammography or MRI
- Subjects who are unable to read, understand and execute the informed consent procedure.
- Subjects who have had mammography ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
- Subjects who have significant existing breast trauma.
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- Subjects who have undergone lumpectomy/mastectomy.
- Subjects who have undergone breast reduction or breast augmentation.
- Subjects who have undergone any other type of breast surgery, excluding surgical biopsy.
- Subjects who have large breast scar / Breast deformation
- Subjects who have undergone a breast needle biopsy or a surgical biopsy within the 6 month period prior to their intended enrollment into the study.
- Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging
- Subjects who are pregnant or lactating
- Subjects with known Raynaud's Disease
- Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.
- Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices
- Subject with kidney failure
- Subject with known allergy to gadolinium
- Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
- Inmates (45 CFR 46.306) or mentally disabled individuals
- Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy)
- Subjects currently participating in another investigational clinical study
- Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase
Trial locations and contacts
1 site in 1 country.
United States1 site
MemorialCare Breast Center, Saddleback Memorial
Laguna Hills, California, 92653
About this study
Official title: Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.
- Conditions
- Breast Cancer
- Being tested
- MIRA device imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRA device imagingDevice
Also called Real Imager 8
MIRA Device imaging for adjunctive detection of breast cancer
| Study group | Role | What they receive |
|---|---|---|
| MIRA device imaging | Experimental | MIRA Device imaging for adjunctive detection of breast cancer Receives: Device: MIRA device imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionOct 2018
Why it stopped: Sponsor decision, not safety related
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.
- 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
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Izhaky, Study director, Real Imaging Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777164
- Sponsor's protocol ID
- 960-CSP-USA_MIRA_USS2
- Status last verified
- May 2019
- First submitted
- 17 May 2016
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT02777164
- Acronym / sponsor ID
- 960-CSP-USA_MIRA_USS2
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, not safety related
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Real Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 19 May 2016 (estimated)
- 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 objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIRA device imaging | Experimental | Device: MIRA device imagingMIRA Device imaging for adjunctive detection of breast cancer |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are asymptomatic and scheduled to undergo routine screening mammography
- OR
- Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care imaging modalities
- AND
- Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously dense breast tissue (Density C or D)
Key exclusion criteria (23 listed)
- Male by birth.
- Individual is less than 30 and greater than 70 years old.
- Contraindication to bilateral mammography or MRI
- Subjects who are unable to read, understand and execute the informed consent procedure.
- Subjects who have had mammography ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
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 |
|---|---|---|
| MIRA device imagingAlso: Real Imager 8MIRA Device imaging for adjunctive detection of breast cancer | Device | MIRA device imaging |
Primary outcome
The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.
Time frame: 19 months
Results and safety
The study was stopped early (reason given: Sponsor decision, not safety related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Sponsor's Web siteLink provided by the sponsor.
- 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.
David Izhaky study director
Real Imaging Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRA device imaging in people with Breast Cancer, run by Real Imaging Ltd. at 1 site in United States.
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 5 inclusion and 23 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: stopped early, as of the sponsor's last update on 3 May 2019. 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 United States. 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 was stopped early (reason given: Sponsor decision, not safety related). Results are not available in the source record.
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?
The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone. (time frame: 19 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 3 May 2019.