CONFIDENCE Registry (CONFIDENCE)

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.

Study Overview

• Status: Completed
• Conditions: Breast Abnormality Diagnosis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Hospital
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Hengelo, Netherlands, 7555 DL
    • Zorggroep Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Imagio OA/US; Imagio optoacoustic	Device: Imagio OA/US; Imagio optoacoustic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity, negative likelihood ratio, sensitivity and positive likelihood	This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations	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	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	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	September 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of lymph node lesions/masses the device is used for	This parameter will be reviewed for the Safety population	September 2024
Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)	This parameter will be reviewed for the Safety population	September 2024
Incidence and nature of device and procedure related adverse events	This parameter will be reviewed for the Safety population	September 2024

Collaborators and Investigators

• Sponsor: Seno Medical Instruments Inc.
• Collaborators: American College of Radiology

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities
• Other Study ID Numbers: CONFIDENCE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: September 2024

IPD Sharing 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

• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• 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