Breast Abnormality DiagnosisCONFIDENCENCT05084729
CONFIDENCE Registry
An observational study of Breast Abnormality Diagnosis, run by Seno Medical Instruments Inc. at 3 sites in Netherlands.
Trial summary
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Abnormality Diagnosis
- What is being tested?
- Imagio OA/US
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 3 sitesNetherlands
- Study dates
- 11 Sep 2020to 19 Jul 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of up to 600 subjects will be enrolled in the registry in up to 12 sites in the EU and US, with a maximum of 50-100 subjects per site. Subjects with lesions/masses presenting with BI-RADS 0-6 will be enrolled. Enrollment into the registry will allow for only 100 lesions/masses presenting with BI-RADS 1 and 2 breast imaging findings and evaluated with the Imagio breast imaging system and 50 lesions/masses presenting with BI-RADS 0 findings and evaluated with the Imagio breast imaging system. This limitation is applicable in order to ensure a cross section of BI-RADS categories enrolled in the registry.
Inclusion Criteria - Subjects must meet all the following criteria to be included in the registry:
- Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
- Are females 18 years of age or older at the time of consent,
- Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system.
Exclusion Criteria - Aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry:
- Are pregnant.
- Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast.
- Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
- Are currently undergoing phototherapy.
- Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus).
- Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
- Have previously participated in this registry,
- Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem, 6815 AD
University Medical Center Groningen
Groningen, 9713 GZ
Zorggroep Twente
Hengelo, 7555 DL
About this study
Official title: A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.
Read the detailed description
This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.
- Conditions
- Breast Abnormality Diagnosis
- Being tested
- Imagio OA/US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagio OA/USDevice
Imagio optoacoustic
| Study group | Role | What they receive |
|---|---|---|
| Imagio OA/US | Imagio optoacoustic Receives: Device: Imagio OA/US |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity, negative likelihood ratio, sensitivity and positive likelihood
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Measured: September 2024
Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Measured: September 2024
Quality of Life Assessment - Testing Morbidity Index
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Measured: September 2024
In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker
i.e., the correlation of Imagio OA/US feature scoring with histologic grade, ER and PR hormone receptors, HER2 receptor (IHC and/or HER2 FISH), Ki-67 proliferative index, as well as with molecular subtypes of breast cancer.
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Measured: September 2024
Secondary outcomes (3)
Characteristics of lymph node lesions/masses the device is used for
This parameter will be reviewed for the Safety population
Measured: September 2024
Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)
This parameter will be reviewed for the Safety population
Measured: September 2024
Incidence and nature of device and procedure related adverse events
This parameter will be reviewed for the Safety population
Measured: September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start11 Sep 2020
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Abnormality DiagnosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Seno Medical Instruments Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084729
- Sponsor's protocol ID
- CONFIDENCE-01
- Acronym
- CONFIDENCE
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Your medical history, information from your medical record (i.e., Imagio images, other standard imaging (screening/diagnostic ultrasounds, MRI, diagnostic ultrasound, Mammography, etc.), pathology results, and other information you give us during an interview or from questionnaires, demographic information like your age, ethnicity or race). In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health information. Initials and numbers will be used on any photocopies of your study records. If the results of this study are reported in medical journals or at meetings, you will not be identified. Every effort is made to ensure that your personal information is removed from these images.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
- ClinicalTrials.gov ID
- NCT05084729
- Acronym / sponsor ID
- CONFIDENCE / CONFIDENCE-01
- Conditions
- Breast Abnormality Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 20 Oct 2021 (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.
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.
Detailed description
This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imagio OA/US | – | Device: Imagio OA/USImagio optoacoustic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of up to 600 subjects will be enrolled in the registry in up to 12 sites in the EU and US, with a maximum of 50-100 subjects per site. Subjects with lesions/masses presenting with BI-RADS 0-6 will be enrolled. Enrollment into the registry will allow for only 100 lesions/masses presenting with BI-RADS 1 and 2 breast imaging findings and evaluated with the Imagio breast imaging system and 50 lesions/masses presenting with BI-RADS 0 findings and evaluated with the Imagio breast imaging system. This limitation is applicable in order to ensure a cross section of BI-RADS categories enrolled in the registry.
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 |
|---|---|---|
| Imagio OA/USImagio optoacoustic | Device | Imagio OA/US |
Primary outcome
Specificity, negative likelihood ratio, sensitivity and positive likelihood
Time frame: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy
Time frame: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Quality of Life Assessment - Testing Morbidity Index
Time frame: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker
Time frame: September 2024
i.e., the correlation of Imagio OA/US feature scoring with histologic grade, ER and PR hormone receptors, HER2 receptor (IHC and/or HER2 FISH), Ki-67 proliferative index, as well as with molecular subtypes of breast cancer. This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
3 secondary outcomes
Characteristics of lymph node lesions/masses the device is used for
Time frame: September 2024
Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)
Time frame: September 2024
Incidence and nature of device and procedure related adverse events
Time frame: September 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes. Your medical history, information from your medical record (i.e., Imagio images, other standard imaging (screening/diagnostic ultrasounds, MRI, diagnostic ultrasound, Mammography, etc.), pathology results, and other information you give us during an interview or from questionnaires, demographic information like your age, ethnicity or race). In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health information. Initials and numbers will be used on any photocopies of your study records. If the results of this study are reported in medical journals or at meetings, you will not be identified. Every effort is made to ensure that your personal information is removed from these images.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Abnormality Diagnosis, run by Seno Medical Instruments Inc. at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Specificity, negative likelihood ratio, sensitivity and positive likelihood (time frame: September 2024). The study lists 4 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 10 Oct 2023.