Breast CancerCOBRISNCT05914168
Clinical Data Collection in Breast Tomosynthesis (COBRIS)
A study testing Breast Tomosynthesis in people with Breast Cancer, run by GE Healthcare at 1 site in France.
Trial summary
The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to Feb 2024
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 35 years or older;
- Women referred for unilateral or bilateral 2D and 3D mammography;
- Women able and willing to comply with study procedures;
- Women able and willing to participate in this study who have signed and dated the informed consent form; and
- Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test
Who cannot join
- Women who have been previously included in this study; or
- Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or
- Women with BRCA 1 or BRCA 2 gene mutation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif
Corinne Balleyguier, MD
About this study
Official title: Clinical Data Collection in Breast Tomosynthesis: COBRIS
The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.
- Conditions
- Breast Cancer
- Being tested
- Breast Tomosynthesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast TomosynthesisDevice
Three dimensional mammography
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Subjects with investigational acquisition Receives: Device: Breast Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Collect clinical breast images obtained with the investigational application.
Measured: 1 year
Secondary outcomes (1)
Assessment of Image Quality
Assess image quality through subjective and open expert evaluation of patient motion, visibility of replication artefacts and visibility of clinical findings.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (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.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balleyguier, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914168
- Sponsor's protocol ID
- 179549298
- Acronym
- COBRIS
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection in Breast Tomosynthesis: COBRIS
- ClinicalTrials.gov ID
- NCT05914168
- Acronym / sponsor ID
- COBRIS / 179549298
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Jun 2023 (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 an image acquisition application for breast tomosynthesis in a clinical environment
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Breast TomosynthesisSubjects with investigational acquisition |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 35 years or older;
- Women referred for unilateral or bilateral 2D and 3D mammography;
- Women able and willing to comply with study procedures;
- Women able and willing to participate in this study who have signed and dated the informed consent form; and
- Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test
Key exclusion criteria (3 listed)
- Women who have been previously included in this study; or
- Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or
- Women with BRCA 1 or BRCA 2 gene mutation
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 |
|---|---|---|
| Breast TomosynthesisThree dimensional mammography | Device | Study arm |
Primary outcome
Data Collection
Time frame: 1 year
Collect clinical breast images obtained with the investigational application.
1 secondary outcome
Assessment of Image Quality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- 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.
Balleyguier principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Tomosynthesis in people with Breast Cancer, run by GE Healthcare at 1 site in France.
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 3 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 22 Jun 2023. 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 France. 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 Jean-Paul Antonini (+33 6 87706729, jean-paul.antonini@ge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: 1 year). 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 22 Jun 2023.