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

Plain Language Summary

Simplified for easier understanding

This study is testing a new AI-enhanced near-infrared imaging system that helps surgeons locate the parathyroid glands (tiny glands in the neck) during thyroid or parathyroid surgery, to reduce the risk of accidentally removing or damaging them. **You may be eligible if...** - You are 18 or older - You are scheduled for elective thyroid removal (total or partial) or parathyroid surgery - You are willing and able to provide written consent **You may NOT be eligible if...** - You have had prior neck surgery or radiation to the neck that could distort normal anatomy - You are pregnant or breastfeeding - You have confirmed or suspected cancer of the parathyroid gland - Your surgery requires removal of the surrounding tissue en bloc (wider resection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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