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

"Early R&D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"

Thyroid Feasibility Study

This is an early R&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules

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.