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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05084729
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
American College of Radiology
Information provided by (Responsible Party):
Seno Medical Instruments Inc.

Brief 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.

Condition or disease Intervention/treatment
Breast Abnormality Diagnosis Device: Imagio OA/US

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Imagio OA/US
Imagio optoacoustic
Device: Imagio OA/US
Imagio optoacoustic

Primary Outcome Measures :
  1. 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

  2. Use of the Imagio system in comparison to and in combination with other imaging modalities in 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

  3. 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

  4. 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

Secondary Outcome Measures :
  1. Characteristics of lymph node lesions/masses the device is used for [ Time Frame: September 2024 ]
    This parameter will be reviewed for the Safety population

  2. Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions) [ Time Frame: September 2024 ]
    This parameter will be reviewed for the Safety population

  3. Incidence and nature of device and procedure related adverse events [ Time Frame: September 2024 ]
    This parameter will be reviewed for the Safety population

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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:

  1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
  2. Are females 18 years of age or older at the time of consent,
  3. 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:

  1. Are pregnant.
  2. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast.
  3. Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
  4. Are currently undergoing phototherapy.
  5. Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus).
  6. Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
  7. Have previously participated in this registry,
  8. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05084729

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Contact: Shaan Schaeffer (210) 615-6501

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Rijnstate Hospital Recruiting
Arnhem, Netherlands, 6815 AD
Contact: Carla Meeuwis, MD         
Principal Investigator: Carla Meeuwis, MD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Monique Dorrius, Dr         
Principal Investigator: Monique Dorrius, Dr         
Zorggroep Twente Recruiting
Hengelo, Netherlands, 7555 DL
Contact: Jeroen Veltman, MD         
Principal Investigator: Jeroen Veltman, MD         
Sponsors and Collaborators
Seno Medical Instruments Inc.
American College of Radiology
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Responsible Party: Seno Medical Instruments Inc. Identifier: NCT05084729    
Other Study ID Numbers: CONFIDENCE-01
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: September 2024
Access Criteria:

The following groups can access the IPD.

To assess accuracy of Imagio:

  • Study staff
  • Imaging Core Lab
  • Seno
  • Doctors, independent of your doctor's office

Institutions and other persons who are required to review research and monitor medical products/therapies and the conduct of research:

  • FDA
  • DHHS
  • Other U.S. and foreign government authorities
  • Institutional Review Boards
  • Seno representatives

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Congenital Abnormalities