CONFIDENCE Registry

NCT05084729 | Completed FDA Device

• 1 other identifier: CONFIDENCE-01
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Abnormality Diagnosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Characteristics of lymph node lesions/masses the device is used for

  September 2024

• Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)

  September 2024

• Incidence and nature of device and procedure related adverse events

  September 2024

Study Arms (1)

Imagio OA/US

Imagio optoacoustic

Device: Imagio OA/US

Interventions

Imagio OA/US DEVICE

Imagio optoacoustic

Imagio OA/US

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead
• American College of Radiology: collaborator

Study Sites (3)

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Zorggroep Twente

Hengelo, 7555 DL, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: September 11, 2020
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

NL (3)