Tri-modal Imaging Instrument for Thyroid Cancer

NCT02758158 | Completed

• 1 other identifier: 15-9101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasms; Thyroid Cancer; Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

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

  up to 5 months

Study Arms (1)

Tri-modal imaging

EXPERIMENTAL

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

Device: Tri-modal imaging

Interventions

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.

Tri-modal imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with thyroid nodules (cancerous, benign or undetermined)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: May 2, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

CA (1)