RecruitingNCT07010380

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


Sponsor

Bo Wang,MD

Enrollment

180 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

Interventions

DEVICEPTFinder 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).

OTHEROffline Machine-Learning Algorithm (PTFinder-AI Beta)

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


Locations(1)

Fujian Medical University Union Hospital

Fuzhou, FJ, China

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NCT07010380


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