Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. As previously shown, it is possible to discriminate the thyroid from the parathyroid glands according to the spectral characteristics, but the HSI technology would add the spatial information, thus enormously enhancing the intraoperative performance. In collaboration with the University of Leipzig, Germany, the investigators performed a clinical pilot trial on 8 patients, which showed promising results. Hyperspectral images during benign endocrine surgery procedures were able to demonstrate that thyroid and parathyroid have specific hyperspectral signatures. Furthermore, the parathyroid glands showed usually less oxygenated than the thyroid. A discrimination of the parathyroid glands based on these characteristics is proven to be possible. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04745793
Study type Observational
Source IHU Strasbourg
Contact
Status Terminated
Phase
Start date January 20, 2021
Completion date October 15, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05975866 - The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato N/A
Terminated NCT04589884 - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Completed NCT00569920 - Nausea and Pain Prophylaxis During Thyroid Surgery N/A
Recruiting NCT05917067 - Fluorescence Imaging of the Parathyroid Glands of Children
Completed NCT04704349 - Latest Imaging SPECT System Evaluation Phase 1 N/A
Recruiting NCT05430139 - Dried Blood Spot Testing for At Home Health
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Recruiting NCT05678374 - Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
Not yet recruiting NCT04094493 - Vit D Role in Post Thyroidectomy Hypocalcemia Early Phase 1
Completed NCT03157466 - Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome
Completed NCT04542278 - Preoperative Steroids in Autoimmune Thyroid Disease Phase 4
Completed NCT04425512 - Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy N/A
Recruiting NCT05510609 - Three-dimensional Ultrasonography Thyroid Volume Measurement. N/A
Recruiting NCT05412680 - Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) N/A
Completed NCT06227819 - BVA-200 vs BVA-100 Validation Study
Completed NCT00150033 - Health-Related Quality of Life for Thyroid Patients Phase 2
Active, not recruiting NCT04351945 - Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Enrolling by invitation NCT04411290 - Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases