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
This trial does not accept healthy volunteersQualifiers
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 population
Consecutive adult patients undergoing thyroid or parathyroid surgery at three tertiary endocrine-surgery centers in China (Fuzhou, Xiamen, and Wenzhou). Approximately 60 participants will be enrolled per center, for a planned total of 180 surgical specimens. The cohort reflects routine clinical practice and is intended to evaluate the ex-vivo performance of the PTFinder near-infrared autofluorescence imaging device.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PTFinder Dual-Channel NIR Autofluorescence Imaging System
DeviceEx 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)
Other interventiontraining/validation on de-identified NIR/RGB frames.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Surgical Specimen Cohort2 interventions
Trial outcomes
Primary outcomes
1
Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder)
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).
Time frame
Intra-operative imaging session (0-5 minutes)Secondary outcomes
1
Time to First Parathyroid Gland Identification (PTFinder)
Seconds from start of device scanning to first verified gland highlight (stopwatch). Lower value indicates faster localisation.
Time frame
1 day (Same imaging session)2
Sensitivity of PTFinder
True-positive glands / (true-positive + false-negative) versus frozen pathology/PTH strip. Unit = %.
Time frame
1 day (Same imaging session)3
Specificity of PTFinder
True-negative sites / (true-negative + false-positive). Unit = %.
Time frame
1 day (Same imaging session)4
Serum PTH Level
Mean parathyroid hormone concentration (pg/mL) at each time-point.
Time frame
1 hour , 24 hours, 7 days post-opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bo Wang,MD
Lead sponsor
Fujian Medical University
Sponsor institution
Source ClinicalTrials.gov