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Recruiting Observational

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

NCT07010380 · tracked via the Priya Life Science China tracker
Sponsor
Bo Wang,MD
Phase
Observational
Started
2025-06-01
Last updated
2025-06-18

Condition(s) studied

Thyroid NeoplasmsHyperparathyroidismParathyroid Gland

Investigational drug(s) / intervention(s)

PTFinder Dual-Channel NIR Autofluorescence Imaging SystemOffline Machine-Learning Algorithm (PTFinder-AI Beta)

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).

Offline Machine-Learning Algorithm (PTFinder-AI Beta): training/validation on de-identified NIR/RGB frames.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder) — Intra-operative imaging session (0-5 minutes)
    Proportion of parathyroid glands correctly located by PTFinder divided by the total number of glands confirmed on frozen section or rapid PTH strip. Unit = % (higher = better).

Trial sites (1)

FacilityCityRegionStatus
Fujian Medical University Union Hospital Fuzhou FJ Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07010380 on ClinicalTrials.gov ↗ ← All trials in China