Breast CancerNCT03288792
A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts
A study testing RI8 device imaging in people with Breast Cancer, run by Real Imaging Ltd. at 5 sites in United States.
Trial summary
The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- RI8 device imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Apr 2018to 30 Apr 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects whose most recent (within 18 months) prior mammogram interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D) breast tissue.
- AND
- 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 (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.
Who cannot join
- Male by birth.
- Individual is less than 40 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 RI8 scan.
- Subjects who are pre-menopausal and are between the 14th and 28th day after the start of the menstrual cycle
Show all 28Show fewer
- 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, including surgical biopsy.
- Subjects who have large breast scar / breast deformation
- Subjects who have undergone a breast needle biopsy within the 6-week period prior to their intended enrollment into the study.
- Subjects who have a temperature > 100° F (37.8C) degrees on the day of the RI8 imaging.
- Subjects who are pregnant or lactating.
- Subjects with known Raynaud's Disease.
- Subjects with known Mastitis.
- Subjects diagnosed with epileptic seizures.
- Subjects with weight > 135kg (~300 Lbs.).
- Subjects who 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.
- 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.
- Subject scheduled for a biopsy due to suspicious symptomatic lump
- Subjects who participated in the Validation Phase will not be able to participate in the Testing Phase
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Doris Shaheen Breast Health Center Piedmont Hospital
Atlanta, Georgia, 30309
Memorial Healthcare System
Hollywood, Florida, 33021
MD Anderson Cancer Center
Houston, Texas, 77030
The Jackson Clinic
Jackson, Tennessee, 38305
Saddleback MemorialCare Breast Center
Laguna Hills, California, 92653
About this study
Official title: A Prospective Multicenter Evaluation of Three Dimensional Functional Metabolic and Risk Assessment System in Women With Mammographically Dense Breasts
The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.
- Conditions
- Breast Cancer
- Being tested
- RI8 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.
RI8 device imagingDevice
Also called Real Imager 8
RI8 Device imaging for adjunctive detection of breast cancer
| Study group | Role | What they receive |
|---|---|---|
| RI8 device imaging | Experimental | RI8 Device imaging for adjunctive detection of breast cancer Receives: Device: RI8 device imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the area under the ROC curve when comparing mammography plus RI8 result to mammography alone.
Measured: 18 months
All adverse events and serious adverse events caused by the imaging session as judged by the physician.
Measured: 18 months
Secondary outcomes (1)
Sensitivity and specificity will be computed based on the forced BI-RADS assessment of each mammography case alone and mammography plus RI8.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start15 Apr 2018
- Primary completion9 Apr 2019
- Study completion30 Apr 2019
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
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288792
- Sponsor's protocol ID
- 960-CSP-USA_DenseBreasts_USS1
- Status last verified
- May 2019
- First submitted
- 18 Sep 2017
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Prospective Multicenter Evaluation of Three Dimensional Functional Metabolic and Risk Assessment System in Women With Mammographically Dense Breasts
- ClinicalTrials.gov ID
- NCT03288792
- Acronym / sponsor ID
- 960-CSP-USA_DenseBreasts_USS1
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, not safety related
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Real Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 20 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 purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RI8 device imaging | Experimental | Device: RI8 device imagingRI8 Device imaging for adjunctive detection of breast cancer |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects whose most recent (within 18 months) prior mammogram interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D) breast tissue.
- AND
- 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 (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.
Key exclusion criteria (28 listed)
- Male by birth.
- Individual is less than 40 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 RI8 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 |
|---|---|---|
| RI8 device imagingAlso: Real Imager 8RI8 Device imaging for adjunctive detection of breast cancer | Device | RI8 device imaging |
Primary outcome
Difference in the area under the ROC curve when comparing mammography plus RI8 result to mammography alone.
Time frame: 18 months
All adverse events and serious adverse events caused by the imaging session as judged by the physician.
Time frame: 18 months
1 secondary outcome
Sensitivity and specificity will be computed based on the forced BI-RADS assessment of each mammography case alone and mammography plus RI8.
Time frame: 18 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RI8 device imaging in people with Breast Cancer, run by Real Imaging Ltd. at 5 sites 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 28 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 5 sites 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?
Difference in the area under the ROC curve when comparing mammography plus RI8 result to mammography alone. (time frame: 18 months). The study lists 2 primary outcomes in all. 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.