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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Specimen Cohort | Adults (≥18 y) undergoing thyroid or parathyroid surgery; their excised specimens will be imaged ex vivo with the PTFinder device for parathyroid-gland identification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTFinder Dual-Channel NIR Autofluorescence Imaging System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Intra-operative imaging session (0-5 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Parathyroid Gland Identification (PTFinder) | Seconds from start of device scanning to first verified gland highlight (stopwatch). Lower value indicates faster localisation. | 1 day (Same imaging session) |
| Sensitivity of PTFinder |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Wang Professor, MD | Contact | +86 13959123550 | wangbo@fjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | FJ | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39034960 | Background | Wang B, Zhou CP, Ao W, Cai SJ, Ge ZW, Wang J, Huang WY, Yu JF, Wu SB, Yan SY, Zhang LY, Wang SS, Wang ZH, Hua S, Abdelhamid Ahmed AH, Randolph GW, Zhao WX. Exploring near-infrared autofluorescence properties in parathyroid tissue: an analysis of fresh and paraffin-embedded thyroidectomy specimens. J Biomed Opt. 2025 Jan;30(Suppl 1):S13702. doi: 10.1117/1.JBO.30.S1.S13702. Epub 2024 Jul 18. |
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De-identified individual-level data-NIR/RGB image files, time-to-detection, pathology confirmation, and postoperative PTH & calcium values-will be available 6 months after the primary manuscript is published, for 3 years, to qualified researchers who provide a methodologically sound proposal and sign a data-use agreement. Requests should be sent to the Principal Investigator (wangbo@fjmu.edu.cn).
"De-identified image dataset and trained AI weights will be deposited in an open repository (e.g., Zenodo) 6 months after publication, pending IRB approval."
Researchers must obtain IRB approval or exemption and agree to use the data only for scientific purposes.
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| Offline Machine-Learning Algorithm (PTFinder-AI Beta) | Other | training/validation on de-identified NIR/RGB frames. |
|
True-positive glands / (true-positive + false-negative) versus frozen pathology/PTH strip. Unit = %.
| 1 day (Same imaging session) |
| Specificity of PTFinder | True-negative sites / (true-negative + false-positive). Unit = %. | 1 day (Same imaging session) |
| Serum PTH Level | Mean parathyroid hormone concentration (pg/mL) at each time-point. | 1 hour , 24 hours, 7 days post-op |
| Corrected Serum Calcium Level | Mean calcium (mmol/L) adjusted for albumin. | 1 hour , 24 hours, 7 days post-op |
| Incidence of Hypocalcaemia | % of participants with corrected calcium <2.0 mmol/L or symptoms requiring supplementation. | Up to 7 days post-op |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D006961 | Hyperparathyroidism |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D010279 | Parathyroid Diseases |
| D007154 | Immune System Diseases |
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