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RECRUITINGOBSERVATIONAL

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

A Multicenter Prospective Paired Observational Study Evaluating the Performance of the PTFinder Dual-Channel Near-Infrared and White-Light Imaging System With AI-Assisted Analysis for Rapid Identification of Parathyroid Glands in Surgical Specimens

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years. - Scheduled for elective total thyroidectomy, hemithyroidectomy, or parathyroidectomy with removal of thyroid/parathyroid tissue. - Able and willing to provide written willing to sign a consent form for participation and specimen imaging. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

PTFinder Dual-Channel NIR Autofluorescence Imaging System

Ex vivo, non-contact imaging of resected thyroid/parathyroid specimens; captures near-infrared autofluorescence and overlays it on white-light video to highlight parathyroid glands (2-5 min per specimen).

OTHER

Offline Machine-Learning Algorithm (PTFinder-AI Beta)

training/validation on de-identified NIR/RGB frames.

Locations (1)

Fujian Medical University Union Hospital
Fuzhou, FJ, China