Precise Recognition With Enhanced Vision of Endocrine Neck Targets
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Comparison of the intraoperative detection rate between the Fluobeam®, against the surgeon's clinical appreciation.
研究概览
简要总结
Iatrogenic injuries to the parathyroid glands during thyroid surgery or to the recurrent laryngeal nerve (RLN) do still occur, requiring often specialized management.
Recently, it has been demonstrated that the parathyroid gland shows a significant autofluorescence. Using a commercially available Near-InfraRed (NIR) camera (Fluobeam®, Fluoptics©, France), the parathyroid glands can be clearly visualized by contrast-free fluorescence imaging. However it lacks real-time quantification of the fluorescence intensity.
The hyperspectral imaging (HSI), which is a technology that combines a spectrometer to a camera system, examines the optical properties of a large area in a wavelength range from NIR to visual light (VIS). It provides spatial information real time, in a contact-free, non-ionizing manner. The HSI technology would add the spatial information, thus enormously enhancing the intraoperative performance.
The aim of the proposed study is to identify the spectral features of the important neck target structures, in particular the parathyroid glands, using an appropriate deep learning algorithm, to perform an automated parathyroid recognition. Additionally, this study proposes to compare the detection rate of the hyperspectral based parathyroid recognition with the already existing NIR autofluorescence based recognition.
详细描述
The major challenge in thyroid and parathyroid procedures, is the safe identification of the recurrent laryngeal nerve (RLN) and the localization of the parathyroid glands (to be preserved or to be selectively removed). Iatrogenic injuries to the parathyroid glands during thyroid surgery (resulting in transient or permanent hypocalcemia) or to the RLN (resulting in hoarseness, dysphonia, dyspnea) do still occur, requiring often specialized management.
The percentage of incidental parathyroidectomies, in specialized endocrine centers, is around 16%. In these cases, it is more likely to observe clinical relevant hypocalcemia than after planned parathyroidectomy for hyperparathyroidism. Therefore, there is a critical need for an intra-operative method enabling a precise, real-time parathyroid identification.
Recently, it has been demonstrated that the parathyroid gland shows a significant autofluorescence, which is caused by the optical properties of a still unknown intrinsic fluorophore. When the gland is excited by a light source with a wavelength ranging from 750-785 nm, it emits a fluorescence peak around 820 nm. Taking advantage of this property, Falco et al., using a commercially available NIR camera (Fluobeam®, Fluoptics©, France), could clearly visualize the parathyroid glands by contrast-free fluorescence imaging and could easily discriminate them from the thyroid and the surrounding tissue. The drawback with this autofluorescence-based imaging is that it lacks real-time quantification of the fluorescence intensity.
The hyperspectral imaging (HSI), which is a technology that combines a spectrometer to a camera system, examines the optical properties of a large area in a wavelength range from near infrared (NIR) to visual light (VIS). It provides diagnostic information about the tissue physiology, composition and perfusion. The fact that the HSI produces pictures, thus providing spatial information real time, in a contact-free, non-ionizing manner, makes it potentially a very valuable tool for the intraoperative use.
HSI has exhibited its great potential in the medical field especially in the diagnosis of various neoplasia (e.g. of the cervix, breast, colon, brain), in the detection of perfusion pattern in patients with peripheral arterial disease and in the area of wound diagnostic.
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
- •Man or woman over 18 years old.
- •Patient with benign or malignant pathology of the thyroid or parathyroid gland
- •Patient with no contraindication to anesthesia and surgery
- •Patient able to receive and understand information related to the study
- •Patient affiliated to the French social security system.
排除标准
- •Patient who needs an emergency surgery
- •Pregnant or lactating patient.
- •Patient under guardianship or trusteeship.
- •Patient under the protection of justice.
结局指标
主要结局
Comparison of the intraoperative detection rate between the Fluobeam®, against the surgeon's clinical appreciation.
时间窗: 1 day
Detection rate of the parathyroids by the Fluobeam® against the visual identification by the operating surgeon (clinical ground truth) and, if required by the surgeon, against the histopathological examination (extemporaneous anatomopathology = histological ground truth). Also, final pathology will be used as ground truth.
Comparison of the intraoperative detection rate between the automated HSI-based parathyroid recognition against the surgeon's clinical appreciation.
时间窗: 1 day
Detection rate of the parathyroids by the automated HSI-based parathyroid recognition against the visual identification by the operating surgeon (clinical ground truth) and, if required by the surgeon, against the histopathological examination (extemporaneous anatomopathology = histological ground truth). Also, final pathology will be used as ground truth.
次要结局
- Recognition of possible pathology specific HSI spectral features of pathological parathyroid or thyroid glands.(1 month)
- in vivo collection of HSI spectral features of the parathyroid and thyroid glands to successively enable automated recognition.(1 day)
- Detection rate of the recurrent laryngeal nerve against the clinical impression and the intraoperative neuromonitoring.(1 day)
- in vivo collection of HSI spectral signatures of other tissues routinely exposed during neck surgery, such as thyroid, fat, muscle, cartilage and nerves will be collected.(1 day)
- Difference in time to recognition between human eye, Fluobeam® and HSI(1 day)