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Clinical Trials/NCT03032198
NCT03032198TerminatedNot Applicable

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

Seno Medical Instruments Inc.2 sites in 1 country37 target enrollmentStarted: December 4, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
37
Locations
2
Primary Endpoint
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Imagio OA/US Scan

Experimental

Imagio opto-acoustic gray-scale ultrasound scan

Intervention: Imagio OA/US (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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