Tri-modal Imaging Instrument for Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758158
• Other study ID #: 15-9101
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: October 17, 2017
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Device:
• Tri-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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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