Dual-channel near-infrared imaging with AI to locate parathyroid glands
Official title: 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
Run by Fujian Medical University · NCT07010380 · Data updated 2026-11-12
This project tests PTFinder, a device that uses near-infrared autofluorescence and AI to make removed thyroid or parathyroid tissue glow so doctors can quickly and accurately identify parathyroid glands in adults having thyroid or parathyroid surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, FJ) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2029 |
| Registry record updated | June 18, 2025 |
| Trial ID | NCT07010380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) scheduled for elective total thyroidectomy, hemithyroidectomy, or parathyroidectomy who can consent and agree to specimen imaging are eligible.
✕Probably not a fit
Patients with prior neck surgery or irradiation, suspected parathyroid carcinoma requiring en-bloc resection, or those who cannot comply with follow-up are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, paired, observational study at three endocrine-surgery centers enrolling about 180 adults undergoing thyroidectomy or parathyroidectomy. Each removed specimen is scanned with the PTFinder dual-camera NIR autofluorescence system while a stopwatch records time to first gland visualization, then inspected under normal white light by a blinded investigator. All suspected glands and a random negative sample undergo frozen section or rapid PTH testing, with permanent histology resolving discrepancies, and images will train and test a deep-learning algorithm. Postoperative calcium and PTH are measured at 1 hour, 24 hours, and 7 days to relate gland detection to hypocalcaemia risk.
Why it matters
Potential benefit: If successful, faster and more accurate identification of parathyroid tissue could reduce accidental gland loss and lower the risk of postoperative low calcium.
How similar studies have gone: Near-infrared autofluorescence has previously shown good ability to identify parathyroid tissue ex vivo and in situ, but dual-channel imaging combined with integrated AI is a newer approach with limited prior published data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Fujian Medical University Union Hospital
Fuzhou, Fj, China Recruiting
Study contacts
- Study coordinator: Bo Wang Professor, MD
- Email: wangbo@fjmu.edu.cn
- Phone: +86 13959123550
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.