Breast CancerNCT03080155
Evaluation of a Three Dimensional 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 Germany.
Trial summary
The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device. Read more about this study
- Who is it for?
- Ages 30 to 79 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
- 680 participants
- Where
- 1 siteGermany
- Study dates
- Sep 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 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are between 30 to 70 years of age and who are asymptomatic and scheduled to undergo routine breast cancer screening (MRI and/or mammography) OR
- Women who are between 30 to 79 years of age and scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.
Who cannot join
- 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.
Show all 21Show fewer
- 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 > 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 not 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.
- Inmates 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 who participated in the Calibration Phase will not be able to participate in the Testing Phase.
- Subjects currently participating in another investigational clinical study.
- Subjects undergoing breast MR for pre-staging.
- Subjects with known Mastitis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
BrustZentrum
Göttingen
Uwe Fischer, Prof., 0551-82 074 0, info@brustzentrum-goettingen.de
0551 820 742 72
About this study
The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device.
In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.
- 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.
determining MIRA's PPV (positive predictive value)
- The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using positive MRI (MRI BI-RADS >= 3) as a reference test in cohort of women with negative (Mammography BI-RADS 1 or 2).
- The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using the histological diagnosis as the reference test in ALL women participated in the study.
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 posted15 Mar 2017
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Real Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Fischer, Prof., Principal investigator, BrustZentrum, Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080155
- Sponsor's protocol ID
- 960-CLP-GER_Multimodality_GER1
- Status last verified
- Jun 2018
- First submitted
- 7 Mar 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
- NCT03080155
- Acronym / sponsor ID
- 960-CLP-GER_Multimodality_GER1
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Real Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 15 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 purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device.
In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.
Study design
- Primary purpose
- Diagnosis
- 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 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who are between 30 to 70 years of age and who are asymptomatic and scheduled to undergo routine breast cancer screening (MRI and/or mammography) OR
- Women who are between 30 to 79 years of age and scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.
Key exclusion criteria (21 listed)
- 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.
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
determining MIRA's PPV (positive predictive value)
Time frame: 24 months
* The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using positive MRI (MRI BI-RADS >= 3) as a reference test in cohort of women with negative (Mammography BI-RADS 1 or 2). * The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using the histological diagnosis as the reference test in ALL women participated in the study.
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.
Uwe Fischer, Prof. principal investigator
BrustZentrum, Göttingen
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 Germany.
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 2 inclusion and 21 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 Germany. 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?
determining MIRA's PPV (positive predictive value) (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.