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

This is an early R&D Study

Inclusion Criteria:

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 solid or mostly solid thyroid nodule.;

3. 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 ultrasound guided FNAB,
ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy
of at least one thyroid nodule.

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.