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

Primary Purpose

Feasibility Study for Thyroid Indication

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imagio OA/US
Sponsored by
Seno Medical Instruments Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Feasibility Study for Thyroid Indication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Invision Sally Jobe
  • UT Health Science Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imagio OA/US Scan

Arm Description

Imagio opto-acoustic gray-scale ultrasound scan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2017
Last Updated
July 12, 2022
Sponsor
Seno Medical Instruments Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03032198
Brief Title
"Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
Official Title
"Early R&D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Revision to over all corporate strategy
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
June 17, 2018 (Actual)
Study Completion Date
April 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seno Medical Instruments Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Thyroid Feasibility Study
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility Study for Thyroid Indication

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imagio OA/US Scan
Arm Type
Experimental
Arm Description
Imagio opto-acoustic gray-scale ultrasound scan
Intervention Type
Device
Intervention Name(s)
Imagio OA/US
Other Intervention Name(s)
opto-acoustic gray-scale ultrasound
Intervention Description
Diagnostic opto-acoustic gray-scale ultrasound
Primary Outcome Measure Information:
Title
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
Description
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.
Time Frame
12-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Stavros, MD
Organizational Affiliation
Seno Medical, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Invision Sally Jobe
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
UT Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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