"Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
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ClinicalTrials.gov Identifier: NCT03032198 |
Recruitment Status :
Terminated
(Revision to over all corporate strategy)
First Posted : January 26, 2017
Last Update Posted : June 14, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Feasibility Study for Thyroid Indication | Device: Imagio OA/US | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | "Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules" |
Actual Study Start Date : | December 4, 2017 |
Actual Primary Completion Date : | June 17, 2018 |
Actual Study Completion Date : | April 19, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Imagio OA/US Scan
Imagio opto-acoustic gray-scale ultrasound scan
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Device: Imagio OA/US
Diagnostic opto-acoustic gray-scale ultrasound
Other Name: opto-acoustic gray-scale ultrasound |
- Initial assessment of Imagio's ability to distinguish between benign and malignant thyroid nodules. [ Time Frame: 12-24 months ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032198
United States, Colorado | |
Invision Sally Jobe | |
Greenwood Village, Colorado, United States, 80111 | |
United States, Texas | |
UT Health Science Center | |
San Antonio, Texas, United States, 78229 |
Responsible Party: | Seno Medical Instruments Inc. |
ClinicalTrials.gov Identifier: | NCT03032198 |
Other Study ID Numbers: |
Thyroid-01 |
First Posted: | January 26, 2017 Key Record Dates |
Last Update Posted: | June 14, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Thyroid Nodule Thyroid Diseases Endocrine System Diseases Thyroid Neoplasms |
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |