An observational study in Thyroid Neoplasms, Hyperparathyroidism and Parathyroid Gland, sponsored by Bo Wang,MD. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Bo Wang,MD · Observational
Among 160 studies in Thyroid Neoplasms with a site in China — 65 open to participants now, 72 under way, 6 of them phase 3. Thyroid Neoplasms · China.
Among the 160 studies in Thyroid Neoplasms with a site in China, this one is the 35th largest by planned enrollment of the 52 observational ones, is one of 20 that started in 2025, is one of 52 observational ones, reaches primary completion later than 45 of the 71 other live ones, and was the 135th registered.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 180 is close to the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →65 of the 160 studies in Thyroid Neoplasms with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 152 Thyroid Neoplasms studies recruiting now, 96 (63%) set no upper age limit and 27 (18%) stop at 75 or younger; 37 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →160 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 20 started in 2025.
Median enrollment 106 across the 108 interventional studies, 300 across the 52 observational. Of the 47 that completed or were terminated, 6 (13%) have results posted.
29 of 160 have an industry lead sponsor. The 10 most frequent:
Bo Wang,MD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Bo Wang,MD has 4 studies filed under Thyroid Neoplasms — fewer than ten, so there is no comparison to draw.
17 of the studies in Thyroid Neoplasms with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06860971Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma | 2027-01 |
| NCT07459283FindCure Biosciences (ZhongShan) Co., Ltd.The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors | 2026-12 |
| NCT06623500Shandong Provincial HospitalIodine Nutrition Status and Clinical Characteristics of Thyroid Cancer | 2026-12-01 |
| NCT07359586Zhejiang UniversityLaryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia | 2026-12-25 |
| NCT06970353Fudan UniversityPhase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer | 2026-12-30 |
Among the 160 studies in Thyroid Neoplasms with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults (≥18 y) undergoing thyroid or parathyroid surgery; their excised specimens will be imaged ex vivo with the PTFinder device for parathyroid-gland identification.
Device: PTFinder Dual-Channel NIR Autofluorescence Imaging System · Other: Offline Machine-Learning Algorithm (PTFinder-AI Beta)
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).
training/validation on de-identified NIR/RGB frames.
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)
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)
Sensitivity of PTFinder
True-positive glands / (true-positive + false-negative) versus frozen pathology/PTH strip. Unit = %.
Time frame: 1 day (Same imaging session)
Specificity of PTFinder
True-negative sites / (true-negative + false-positive). Unit = %.
Time frame: 1 day (Same imaging session)
Serum PTH Level
Mean parathyroid hormone concentration (pg/mL) at each time-point.
Time frame: 1 hour , 24 hours, 7 days post-op
Corrected Serum Calcium Level
Mean calcium (mmol/L) adjusted for albumin.
Time frame: 1 hour , 24 hours, 7 days post-op
Incidence of Hypocalcaemia
% of participants with corrected calcium \<2.0 mmol/L or symptoms requiring supplementation.
Time frame: Up to 7 days post-op
Plan to share: Yes — 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).
Supporting information: Study protocol, Statistical analysis plan
Time frame: "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."
Access criteria: Researchers must obtain IRB approval or exemption and agree to use the data only for scientific purposes.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2027, 30 months after the start.
Of 103 non-industry observational studies under Thyroid Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 311. This study's planned 30 months is below that.
Counting every sponsor, half of 112 studies reached it within 63 months; a quarter within 26 and three quarters within 311.
How these figures are worked out, and which studies are left out of them.
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Bo Wang,MD