Tri-modal Imaging Instrument for Thyroid Cancer

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.

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tri-modal imaging

Device

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 outcomes

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

Time frame: up to 5 months

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Thyroid Cancer

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 2, 2016
Registry last updated: Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed