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Tri-modal Imaging Instrument for Thyroid Cancer

Primary Purpose

Thyroid Neoplasms, Thyroid Cancer, Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tri-modal imaging
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Neoplasms

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female patients with thyroid nodules (cancerous, benign or undetermined)
  2. 18 years of age or older
  3. Have been consented to their standard-of-care surgery for resection of the thyroid (partial or complete) and lymph nodes (if applicable)
  4. Have had pre-surgical US imaging of the thyroid and lymph nodes

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Pre-operative therapy for current thyroid cancer (including chemotherapy, endocrine therapy and radiotherapy)
  3. History of photosensitivity or skin disease (exposure to laser light is involved in PA imaging)
  4. Pregnancy

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tri-modal imaging

Arm Description

Ultrasound and photoacoustic imaging of thyroid and adjacent lymph nodes. Imaging time: Approximately 30 minutes

Outcomes

Primary Outcome Measures

Detect/localize thyroid nodules and lymph nodes in vivo by using tri-modal imaging

Secondary Outcome Measures

Full Information

First Posted
March 9, 2016
Last Updated
October 17, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02758158
Brief Title
Tri-modal Imaging Instrument for Thyroid Cancer
Official Title
Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using ultrasound imaging and surgery is the most common treatment. However, most nodules are benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound imaging is very sensitive for localizing nodules, but does not differentiate between cancerous and benign ones. To address this limitation of US imaging, investigators have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs complimentary imaging modalities (ultrasound (US), photoacoustic (PA)) that could potentially help diagnose nodules without the need for biopsy and unnecessary surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms, Thyroid Cancer, Thyroid Nodule

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tri-modal imaging
Arm Type
Experimental
Arm Description
Ultrasound and photoacoustic imaging of thyroid and adjacent lymph nodes. Imaging time: Approximately 30 minutes
Intervention Type
Device
Intervention Name(s)
Tri-modal imaging
Intervention Description
This trimodal imaging system was developed in collaboration with Sogang University and is composed of three subsystems: ultrasound, photoacoustic and fluorescence. For this study, the fluorescence subsystem will not be used. The photoacoustic and ultrasound subsystems and data acquisition are controlled by a single workstation. The complete system is Canadian Standards Association (CSA) certified.
Primary Outcome Measure Information:
Title
Detect/localize thyroid nodules and lymph nodes in vivo by using tri-modal imaging
Time Frame
up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients with thyroid nodules (cancerous, benign or undetermined) 18 years of age or older Have been consented to their standard-of-care surgery for resection of the thyroid (partial or complete) and lymph nodes (if applicable) Have had pre-surgical US imaging of the thyroid and lymph nodes Exclusion Criteria: Inability to provide informed consent Pre-operative therapy for current thyroid cancer (including chemotherapy, endocrine therapy and radiotherapy) History of photosensitivity or skin disease (exposure to laser light is involved in PA imaging) Pregnancy
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Tri-modal Imaging Instrument for Thyroid Cancer

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