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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBo Wang,MD

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

180 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bo Wang,MD

Lead sponsor

Fujian Medical University

Sponsor institution