Breast CancerNCT02155075
Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System
A study testing MIRA device imaging in people with Breast Cancer, run by Real Imaging Ltd. at 1 site in Israel.
Trial summary
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of… Read more about this study
- Who is it for?
- Ages 30 years and older, 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
- 730 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Oct 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Woman has read, understood and signed the inform consent form
- Age: 30 years and older
- A. Women who are scheduled to undergo routine Mammography and/or US and/or MRI screening OR B. Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5 on BI-RADS scale
- Female
- Age: 30 years and older
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- A. Asymptomatic women who are scheduled to undergo routine screening mammography or routine screening mammography and US Or B. Subjects scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI).
- 5. Women whose most recent prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D).
- Female
- Age: 30 years and older
- Asymptomatic women who are scheduled to undergo routine screening mammography or routine screening mammography and US
Who cannot join
- Women who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
- Women who had undergone mastectomy and/or breast reconstruction
- Women who have had a breast biopsy performed throughout the 6 weeks preceding the study
- Women who have a fever on the day of the MIRA imaging
- Women who are pregnant
- Women who are breast-feeding
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- Women with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
- Women who are unable to read, understand and execute written informed consent
- Women who are currently undergoing chemotherapy and/or radiotherapy
- PHASE 2:
- ARM 1:
- Subjects who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
- Subjects scheduled for a diagnostic mammography due to a suspicious lump
- Subjects who had undergone mastectomy and/or breast reconstruction
- Subjects who have undergone breast reduction or breast augmentation.
- Subjects who have large breast scar / breast deformation.
- Subjects who have significant existing breast trauma.
- Subjects who have undergone lumpectomy
- Subjects who have had a breast needle biopsy performed throughout the 6 weeks preceding the study
- Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
- Subjects with known Raynaud's Disease.
- Subjects who have a fever on the day of the MIRA imaging
- Subjects who are pregnant
- Subjects who are breast-feeding
- Subjects with known Mastitis
- Subjects who are currently undergoing chemotherapy and/or radiotherapy
- Subjects with contraindication to bilateral mammography or MRI.
- Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
- Subjects currently participating in another clinical study.
- Subjects who are unable to read, understand and execute written informed consent
- ARM 2:
- Subjects who have had a Mammography examination performed on the day of the study prior to MIRA scan
- Subjects scheduled for a diagnostic mammography due to a suspicious lump
- Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study
- Subjects who have a fever on the day of the MIRA imaging
- Subjects who are pregnant
- Subjects who are breast-feeding
- Subjects with known Mastitis
- Subjects with known Raynaud's Disease.
- Subjects who are currently undergoing chemotherapy and/or radiotherapy
- Subjects with contraindication to bilateral mammography
- Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
- Subjects currently participating in another clinical study.
- Subjects who are unable to read, understand and execute written informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Chaim Sheba Medical Center at Tel Hashomer
Ramat Gan, 5262000
Shelly Curtis, 972-50-722-4421, Shelly@realimaging.com
Miri Sklair-Levy, MD
About this study
Official title: Evaluation of Real Imaging's 3d Functional Metabolic Imaging and Risk Assessment (Mira) System
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.
The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in women.
- Conditions
- Breast Cancer
- Being tested
- MIRA device imaging
- Keywords
- Breast neoplasm, Breast implants, Mammography, Breast imaging, Imaging augmented breast
- 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 (RI8)
MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Testing phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant.
All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI. Receives: Device: MIRA device imaging |
| Arm 2 | Experimental | Testing phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path. Receives: Device: MIRA device imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sufficient number of cancer case and controls have been imaged
As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miri Sklair-Levy, MD, Principal investigator, The Chaim Sheba Medical center at Tel-Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155075
- Sponsor's protocol ID
- 960-CSP-ISR_ImplantsMC_ILS3
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2014
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Real Imaging's 3d Functional Metabolic Imaging and Risk Assessment (Mira) System
- ClinicalTrials.gov ID
- NCT02155075
- Acronym / sponsor ID
- 960-CSP-ISR_ImplantsMC_ILS3
- Conditions
- Breast Cancer
- Keywords
- Breast neoplasm, Breast implants, Mammography, Breast imaging, Imaging augmented breast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Real Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 4 Jun 2014 (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.
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.
The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in women.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: MIRA device imagingTesting phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant. All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI. |
| Arm 2 | Experimental | Device: MIRA device imagingTesting phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Woman has read, understood and signed the inform consent form
- Age: 30 years and older
- A. Women who are scheduled to undergo routine Mammography and/or US and/or MRI screening OR B. Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5 on BI-RADS scale
- Female
Key exclusion criteria (44 listed)
- Women who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
- Women who had undergone mastectomy and/or breast reconstruction
- Women who have had a breast biopsy performed throughout the 6 weeks preceding the study
- Women who have a fever on the day of the MIRA imaging
- Women who are pregnant
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 8 (RI8)MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result | Device | Arm 1, Arm 2 |
Primary outcome
Sufficient number of cancer case and controls have been imaged
Time frame: up to 24 months
As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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.
Miri Sklair-Levy, MD principal investigator
The Chaim Sheba Medical center at Tel-Hashomer
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 Israel.
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 11 inclusion and 44 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: status not confirmed, as of the sponsor's last update on 19 Jun 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MIri Sklair-Levy, MD (972-3-5302514, Miri.SklairLevy@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sufficient number of cancer case and controls have been imaged (time frame: up to 24 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 19 Jun 2018.