Clinical trial NCT05084729: CONFIDENCE Registry
Official title: A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Abnormality Diagnosis
Lead sponsor: Seno Medical Instruments Inc.
Sponsor class: INDUSTRY
Collaborators: name: American College of Radiology
First posted: 2021-10-20
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Specificity, negative likelihood ratio, sensitivity and positive likelihood
timeFrame: September 2024
measure: 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
timeFrame: September 2024
measure: Quality of Life Assessment - Testing Morbidity Index
timeFrame: September 2024
measure: In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker
timeFrame: September 2024
Secondary outcomes:
measure: Characteristics of lymph node lesions/masses the device is used for
timeFrame: September 2024
measure: Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)
timeFrame: September 2024
measure: Incidence and nature of device and procedure related adverse events
timeFrame: September 2024
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Hengelo
country: Netherlands
facility: Zorggroep Twente
Study officials:
References: