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Dual-Channel Near-Infrared Autofluorescence Imaging and AI Analysis to Locate Parathyroid Glands (PTFinder)

Recruitingn/aAges 18 Years - anyAllBo Wang,MD
NCT07010380 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study tests PTFinder, a dual-camera system that makes parathyroid glands glow on screen by capturing their natural near-infrared autofluorescence. After a thyroid or parathyroid operation, the removed tissue is scanned with PTFinder and then checked again under normal white light. We will measure how fast (seconds) and how accurately the device finds real glands, confirmed by frozen pathology or a rapid PTH strip. About 180 adult patients at three Chinese hospitals will join. The imaging adds only a few minutes and does not change any part of the surgery. We will also record blood calcium and PTH at 1 h, 24 h, and 7 d after surgery to see whether better gland recovery lowers low-calcium risk.Collected images will also be used to train and test a deep-learning model for fully automated parathyroid recognition; model performance metrics constitute secondary outcomes.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Scheduled for elective total thyroidectomy, hemithyroidectomy, or parathyroidectomy with removal of thyroid/parathyroid tissue. * Able and willing to provide written informed consent for participation and specimen imaging. Exclusion Criteria: * History of neck irradiation or prior neck surgery that may distort parathyroid anatomy. * Pregnancy or breastfeeding. * Confirmed or suspected parathyroid carcinoma, or thyroid carcinoma requiring en-bloc parathyroid resection. * Inability to understand the study procedures or to comply with follow-up.
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What it tests

  • PTFinder Dual-Channel NIR Autofluorescence Imaging System
  • Offline Machine-Learning Algorithm (PTFinder-AI Beta)
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Where

1 site
Fujian Medical University Union Hospital
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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