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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Bo Wang Professor, MD
wangbo@fjmu.edu.cn
+86 13959123550
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 180
Treatments
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.
Sponsors
Leads: Bo Wang,MD

This content was sourced from clinicaltrials.gov