Dual-Channel Near-Infrared Autofluorescence Imaging and AI Analysis to Locate Parathyroid Glands (PTFinder)
- Conditions
- Thyroid NeoplasmsHyperparathyroidismParathyroid Gland
- Registration Number
- NCT07010380
- Lead Sponsor
- Bo Wang,MD
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder) Intra-operative imaging session (0-5 minutes) 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).
- Secondary Outcome Measures
Name Time Method Incidence of Hypocalcaemia Up to 7 days post-op % of participants with corrected calcium \<2.0 mmol/L or symptoms requiring supplementation.
Time to First Parathyroid Gland Identification (PTFinder) 1 day (Same imaging session) Seconds from start of device scanning to first verified gland highlight (stopwatch). Lower value indicates faster localisation.
Sensitivity of PTFinder 1 day (Same imaging session) True-positive glands / (true-positive + false-negative) versus frozen pathology/PTH strip. Unit = %.
Specificity of PTFinder 1 day (Same imaging session) True-negative sites / (true-negative + false-positive). Unit = %.
Serum PTH Level 1 hour , 24 hours, 7 days post-op Mean parathyroid hormone concentration (pg/mL) at each time-point.
Corrected Serum Calcium Level 1 hour , 24 hours, 7 days post-op Mean calcium (mmol/L) adjusted for albumin.
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, FJ, China