Hyperparathyroidism, Parathyroid Gland, Thyroid Neoplasms
Conditions
Keywords
Near-Infrared Autofluorescence (NIRAF), Parathyroid Identification, PTFinder Device, Dual-Channel Imaging, Rapid PTH Test Strip, Thyroidectomy Specimen, Ex-Vivo Fluorescence Camera, Sensitivity and Specificity, Artificial Intelligence, Deep Learning, Computer Vision, NIRAF 3 Dual, PTFinder 3 Dual, PTFinder 3.0 Dual, NIRAF 3.0 Dual
Brief 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.
Detailed description
Prospective, paired, observational study at three endocrine-surgery centers. For each specimen: PTFinder scan - stopwatch runs until the first gland is seen; all suspected glands are marked. White-light exam - second investigator, blinded to device results, inspects the same specimen. All marked tissue plus a random negative sample go to frozen section or rapid PTH strip; discrepancies are settled by permanent histology. Outcomes Primary - time to first gland; detection rate per specimen. Secondary - sensitivity, specificity, PPV, NPV; post-operative PTH and calcium at 1 h, 24 h, 7 d; incidence of hypocalcaemia. Sample size: 60 specimens per site (total = 180) gives 80 % power to detect a rise in detection rate from 70 % to 90 % (α = 0.05, McNemar). Analysis: Paired tests for efficiency, mixed-effects models for accuracy and lab values; multiple imputation for missing data. Safety & Oversight: PTFinder emits low-intensity NIR light only on ex-vivo tissue; no patient exposure. Device is investigational, not under an FDA IDE. Ethics approval obtained from Fujian Medical University Union Hospital IRB (FJMU-IRB-2025-PTF); other sites use the same central IRB agreement. Data are stored in a secure eCRF. 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.
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.
Sponsors
Bo Wang,MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of PTFinder | 1 day (Same imaging session) | True-positive glands / (true-positive + false-negative) versus frozen pathology/PTH strip. Unit = %. |
| Specificity of PTFinder | 1 day (Same imaging session) | True-negative sites / (true-negative + false-positive). Unit = %. |
| Time to First Parathyroid Gland Identification (PTFinder) | 1 day (Same imaging session) | Seconds from start of device scanning to first verified gland highlight (stopwatch). Lower value indicates faster localisation. |
| Corrected Serum Calcium Level | 1 hour , 24 hours, 7 days post-op | Mean calcium (mmol/L) adjusted for albumin. |
| Incidence of Hypocalcaemia | Up to 7 days post-op | % of participants with corrected calcium \<2.0 mmol/L or symptoms requiring supplementation. |
| Serum PTH Level | 1 hour , 24 hours, 7 days post-op | Mean parathyroid hormone concentration (pg/mL) at each time-point. |
Countries
China
Contacts
Primary ContactBo Wang Professor, MD
Outcome results
None listed