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Tri-modal Imaging Instrument for Thyroid Cancer

NCT ID: NCT02758158

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-02-28

Brief Summary

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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

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Conditions

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Thyroid Neoplasms Thyroid Cancer Thyroid Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tri-modal imaging

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

Group Type EXPERIMENTAL

Tri-modal imaging

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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15-9101

Identifier Type: -

Identifier Source: org_study_id