Breast CancerNCT03296683
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer
A study testing MIRA device imaging in people with Breast Cancer, run by Real Imaging Ltd. at 1 site in Italy.
Trial summary
The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer. Read more about this study
- Who is it for?
- Ages 24 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
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2017to Sep 2021
- 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 24 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Calibration Phase:
- A.Subjects who are asymptomatic and scheduled to undergo routine screening mammography.
- OR
- B.Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care (mammography, ultrasound and/or MRI)
- Testing Phase:
- Subjects scheduled to undergo routine screening mammography and at least one of the following :
Show all 29Show fewer
- Subjects whose most recent (within 3 years) prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS Breast Density 4).
- Subjects whose current 10-year IBIS breast cancer risk is 5% or higher.
- EXCLUSION CRITERIA, valid for both calibration and testing phases:
- Male by birth.
- Individual is less than 24 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.
- 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.
- Subjects who have large breast scar / Breast deformation.
- Subjects who have undergone a breast needle 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 who have had placement of an internal breast marker.
- 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.
- Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
- Subjects affected with epilepsy.
- Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico San Donato
San Donato Milanese
Francesco Sardanelli, M.D., 39-02-52774468, f.sardanelli@grupposandonato.it
About this study
Official title: Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer
The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.
- 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.
Increase in incremental cancer detection rate
Statistically significant increase of 30% or more in incremental cancer detection rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start23 May 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2021 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Sardanelli, M.D, Principal investigator, Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296683
- Sponsor's protocol ID
- 960-CLP-ITL_RI8 _ITS1
- Status last verified
- Jun 2018
- First submitted
- 18 Sep 2017
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer
- ClinicalTrials.gov ID
- NCT03296683
- Acronym / sponsor ID
- 960-CLP-ITL_RI8 _ITS1
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Real Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Sep 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 study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.
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
- 24 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- A.Subjects who are asymptomatic and scheduled to undergo routine screening mammography.
- OR
- B.Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care (mammography, ultrasound and/or MRI)
- Subjects scheduled to undergo routine screening mammography and at least one of the following :
- Subjects whose most recent (within 3 years) prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS Breast Density 4).
Key exclusion criteria (0 listed)
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
Increase in incremental cancer detection rate
Time frame: 24 months
Statistically significant increase of 30% or more in incremental cancer detection rate
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.
Francesco Sardanelli, M.D principal investigator
Policlinico San Donato
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 Italy.
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 29 inclusion and 0 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 Italy. 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 David Izhaky (+972-3-972-0602, david@realimaging.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in incremental cancer detection rate (time frame: 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.