Tri-modal Imaging Instrument for Thyroid Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02758158

Enrollment

Registered

2016-05-02

Start date

2016-01-31

Completion date

2017-02-28

Last updated

2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Thyroid Neoplasms, Thyroid Nodule

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.

Interventions

DEVICETri-modal imaging

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Detect/localize thyroid nodules and lymph nodes in vivo by using tri-modal imaging	up to 5 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026