IMAging with opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO other diagnostic methodologies (MAESTRO)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Subjects must meet all of the following criteria to be included in the study:
1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
2. Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan;
3. Are females 18 years of age or older at the time of consent;
4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
5. Have received recommendation for and are scheduled for an image-guided CNB, DVAB, or excisional biopsy of at least one mass.
6. Are willing to have an image-guided CNB, DVAB, or excisional biopsy within 30 days following Imagio evaluation of the breast mass.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:
1. Are males;
2. Are prisoners;
3. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos);
4. Have or have had previously treated (i.e., lumpectomy, partial mastectomy, radiation therapy) cancer in the ipsilateral breast within the same quadrant(s) as the mass(es) to be biopsied;
5. Have had prior benign excisional breast biopsy within the immediate vicinity (within one probe length or 4 cm of the mass) of the currently evaluated suspicious mass within the past 18 months.
6. Have greater than 3 masses recommended for biopsy at baseline;
7. Patient had a previous diagnostic ultrasound of the suspicious mass greater than 3 wekks from the patient*s baseline Imagio scan;
8. Have no mass(es) characterized as BI-RADS 4a or 4b as determined by CDU;
9. Mass to be biopsied is greater than 3.0 cm in maximum diameter;
10. Patient currently has mastitis;
11. Patient has focal pain without thickening or mass within one probe length or 4 cm of the mass;
12. Is pregnant or lactating or planning to become pregnant during study participation;
13. 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 the mass;
14. Have an acute or a chronic hematoma and/or acute ecchymosis of the ipsilateral breast;
15. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
16. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
17. Have had previous image guided CNB, image guided DVAB, or surgical biopsy of the target mass of interest;
18. Have nipple rings that cannot be removed or are not able to be removed during Imagio OA evaluation or infection or inflammation of the nipple ring area;
19. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and,
20. Patient has previously participated in this study.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For benign masses, to evaluate if the Imagio OA technology downgrades BI-RADS<br /><br>4a and 4b classification as indicated by (Conventional Diagnostic Ultrasound)<br /><br>CDU to 3 or 2, for a potentially suspicious breast lesion after a diagnostic or<br /><br>screening evaluation.<br /><br><br /><br>For malignant masses, to evaluate that the Imagio OA technology does not lower<br /><br>the BI-RADS classification from 4a or 4b as determined by CDU to 3 or 2.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To estimate the impact of blinding independent readers relative to the<br /><br>un-blinded site investigator(s).<br /><br>• To compare and estimate that Imagio OA meets other acceptance metrics.<br /><br>• To compare histologic relationships with Imagio OA findings for malignant<br /><br>masses.<br /><br>• To assess the sensitivity and specificity of CDU and Imagio.<br /><br><br /><br>Imagio based nomograms that have been generated in a previous study will be<br /><br>assessed for their abilities to distinguish benign vs malignant and for their<br /><br>abilities to predict POM.</p><br>

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