"Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"

Exclusion Criteria

• •1. Are prisoners;
• •2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule),
• •3. Previous or on-going radioactive iodine treatment.
• •4. Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
• •5. Is pregnant;
• •6. Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
• •7. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
• •8. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
• •9. Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;
• •10. 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,
• •11. Patient has previously participated in this study.