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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Detection Rate of Pathology-Confirmed Parathyroid Glands per Specimen (PTFinder)
时间窗: 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).
次要结局
- Incidence of Hypocalcaemia(Up to 7 days post-op)
- Time to First Parathyroid Gland Identification (PTFinder)(1 day (Same imaging session))
- Sensitivity of PTFinder(1 day (Same imaging session))
- Specificity of PTFinder(1 day (Same imaging session))
- Serum PTH Level(1 hour , 24 hours, 7 days post-op)
- Corrected Serum Calcium Level(1 hour , 24 hours, 7 days post-op)
研究者
Bo Wang,MD
Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor
Fujian Medical University