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

Study Overview
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Brief Summary
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Thyroid Feasibility Study

Detailed Description
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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

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

Conditions
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Feasibility Study for Thyroid Indication

Intervention / Treatment
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* Device: Imagio OA/US


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities; Have an undiagnosed suspicious solid or mostly solid thyroid nodule.; 18 years of age or older at the time of consent; Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and, 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: Are prisoners; 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), Previous or on-going radioactive iodine treatment. Nodule to be biopsied is greater than 3.0 cm in maximum diameter; Is pregnant; Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid; Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus; Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU; Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan; 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, Patient has previously participated in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imagio OA/US Scan<br>Imagio opto-acoustic gray-scale ultrasound scan | Device: Imagio OA/US<br>* Diagnostic opto-acoustic gray-scale ultrasound<br>* Other names: opto-acoustic gray-scale ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules. | The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects. | 12-24 months |