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

Feasibility Study for Thyroid Indication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03032198
• Other study ID #: Thyroid-01
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: April 19, 2019

Study information

• Verified date: July 2022
• Source: Seno Medical Instruments Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thyroid Feasibility Study

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: April 19, 2019
• Est. primary completion date: June 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Feasibility Study for Thyroid Indication
• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Imagio OA/US
Diagnostic opto-acoustic gray-scale ultrasound

Locations

Country	Name	City	State
United States	Invision Sally Jobe	Greenwood Village	Colorado
United States	UT Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seno Medical Instruments Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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