"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

Study Overview

• Status: Terminated
• Conditions: Feasibility Study for Thyroid Indication
• Intervention / Treatment: Device: Imagio OA/US

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Invision Sally Jobe
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imagio OA/US Scan; Imagio opto-acoustic gray-scale ultrasound scan	Device: Imagio OA/US; Diagnostic opto-acoustic gray-scale ultrasound; Other Names: opto-acoustic gray-scale ultrasound

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seno Medical Instruments Inc.
• Investigators: Principal Investigator: Tom Stavros, MD, Seno Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): June 17, 2018
• Study Completion (Actual): April 19, 2019

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: Thyroid-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes