Exploring near-infrared autofluorescence properties in parathyroid tissue: an analysis of fresh and paraffin-embedded thyroidectomy specimens.
Bo Wang, Chi-Peng Zhou, Wei Ao...
https://pubmed.ncbi.nlm.nih.gov/39034960Actively Recruiting
Age: 18Years +
All Genders
ID07010380
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
Led by Bo Wang,MD · Updated on 2025-06-18
180
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the PTFinder system, a device that uses dual-camera near-infrared autofluorescence imaging to make parathyroid glands glow on screen during thyroid or parathyroid surgery. The study aims to measure how quickly and accurately PTFinder identifies real parathyroid glands compared to white-light examination. This observational study involves about 180 adult patients undergoing surgery at three Chinese hospitals and explores whether improved gland detection reduces the risk of low blood calcium after surgery. Additionally, collected images will help develop and test an AI model for automated gland recognition. During the study, excised thyroid or parathyroid tissue specimens will be scanned ex vivo with PTFinder, timing how fast the first gland is found and marking suspected glands. Then, a blinded investigator will examine the same tissue under normal white light. Marked tissue and random negative samples will undergo frozen section or rapid PTH testing, with any differences resolved by permanent histology. The procedure adds only a few minutes to surgery and does not alter the surgical process. The collected data will also be used to train a machine-learning algorithm for parathyroid recognition as a secondary goal. Participants will have blood tests for calcium and parathyroid hormone at 1 hour, 24 hours, and 7 days after surgery to monitor gland recovery and hypocalcemia risk. Data accuracy and device performance will be analyzed statistically, and all information is securely stored. The study involves close monitoring during surgery and post-operative follow-up visits, lasting up to seven days after surgery to evaluate safety and gland function.
CONDITIONS
Brief Title
Dual-Channel Near-Infrared Autofluorescence Imaging and AI Analysis to Locate Parathyroid Glands (PTFinder)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective total thyroidectomy, hemithyroidectomy, or parathyroidectomy with removal of thyroid or parathyroid tissue
- Able and willing to provide written informed consent for participation and specimen imaging
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment prior to surgery
Implementation
Duration - Imaging session lasting up to 5 minutes per specimen on the day of surgery
Participants' excised thyroid or parathyroid specimens are imaged ex vivo using the PTFinder device to identify parathyroid glands.
1 imaging session during surgery
Post-operative Follow-up
Duration - Up to 7 days post-surgery
Participants are monitored post-operatively for serum PTH and corrected calcium levels to assess parathyroid function and incidence of hypocalcaemia.
3 follow-up assessments at 1 hour, 24 hours, and 7 days after surgery
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, FJ, China, 350001
Actively Recruiting
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Research Team
B
Bo Wang Professor, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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