Trial Outcomes & Findings for "Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules" (NCT NCT03032198)

Last Updated: 2022-08-02

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

12-24 months

Results posted on

2022-08-02

Participant Flow

Trial was terminated early due to corporate strategy changes

Participant milestones

Participant milestones
Measure	Imagio OA/US Scan Imagio opto-acoustic gray-scale ultrasound scan Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound
Overall Study STARTED	37
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Imagio OA/US Scan Imagio opto-acoustic gray-scale ultrasound scan Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound
Overall Study Screen Fail	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imagio OA/US Scan n=37 Participants Imagio opto-acoustic gray-scale ultrasound scan Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound
Age, Continuous	57 Years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-24 months

Population: This Early R\&D Development Study was terminated early due to change in corporate strategy. The study was discontinued before we initiated the independent reader portion of the study which would have been the basis for producing the data that is needed for analyzing this endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Imagio OA/US Scan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Imagio OA/US Scan n=36 participants at risk Imagio opto-acoustic gray-scale ultrasound scan Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound
General disorders Pain	2.8% 1/36 • Number of events 1 • AEs were collected during Imagio scanning at baseline

Additional Information

Shaan Schaeffer

Seno Medical, Inc.

Phone: 6106983259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place