Tri-modal Imaging Instrument for Thyroid Cancer

Not Applicable

Completed

• Conditions: Thyroid Neoplasms; Thyroid Cancer; Thyroid Nodule
• Interventions: Device: Tri-modal imaging

• Registration Number: NCT02758158
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tri-modal imaging	Tri-modal imaging	Ultrasound and photoacoustic imaging of thyroid and adjacent lymph nodes. Imaging time: Approximately 30 minutes

Primary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada