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Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Thyroid Cancer (NCT02758158)

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.
  • 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.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Male or female patients with thyroid nodules (cancerous, benign or undetermined)
    • 18 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
    Exclusion Criteria:
    • 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

    1 locations

    Canada (1)
    • Princess Margaret Cancer Centre
      Not specified
      Toronto, Ontario, Canada
    31 December, 2015
    16 October, 2017
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