A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging with Opto-acoustics to Diagnose BrEast CaNCEr

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
2. Are males or females 18 years of age or older at the time of consent,
3. Either have a BI-RADS 1 mammogram (50 subjects) or have been referred for a breast ultrasound because of a breast mass/finding found (2100 subjects) on at least one of the following examinations:
a. Physical palpation or other signs symptoms (i.e. nipple discharge, skin changes, inflammation, etc.),
b. Screening or diagnostic mammography (including 2D mammography or tomosynthesis, CESM),
c. Supplemental screening ultrasound exam and/or CDU,
d. Screening or diagnostic breast MRI,
e. Screening or diagnostic molecular breast imaging (MBI technetium 99m sestamibi scans of the breast),
f. Screening or diagnostic PET/CT or PEM,
4. Be willing and able to complete all procedures and assessments in accordance with the
clinical protocol,
5. Have up to 3 target mass(es) total per subject.

Exclusion Criteria

1. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass),
2. Mass(es) not visible under screening or diagnostic ultrasound (includes Imagio IUS)
3. Are pregnant,
4. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast within one probe length or 4 cm of each mass to be included,
5. Are experiencing photo-toxicity or photo-sensitivity or are undergoing treatment for a photosensitive condition such as porphyria or lupus erythematosus,
6. Have received or are receiving chemotherapy for any type of cancer up to 90 days prior to the date of the baseline Imagio procedure,
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 & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this post market surveillance registry is to provide<br /><br>the real world evidence on the specificity (SP) and negative likelihood ratio<br /><br>(NLR) and the sensitivity (SN) and positive likelihood ratio (PLR) of the<br /><br>Imagio OA/US technology for the indication of breast mass diagnosis as opposed<br /><br>to conventional diagnostic ultrasound (CDU) alone. </p><br>

Secondary Outcome Measures