Thyroid Diseases Clinical Trial
— PREVENTOfficial title:
Precise Recognition With Enhanced Vision of Endocrine Neck Targets
NCT number | NCT04745793 |
Other study ID # | 20-007 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 20, 2021 |
Est. completion date | October 15, 2021 |
Verified date | January 2024 |
Source | IHU Strasbourg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 54 |
Est. completion date | October 15, 2021 |
Est. primary completion date | October 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Patient who needs an emergency surgery - Pregnant or lactating patient. - Patient under guardianship or trusteeship. - Patient under the protection of justice. |
Country | Name | City | State |
---|---|---|---|
France | Service de Chirurgie Digestive et Endocrinienne, NHC | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
IHU Strasbourg |
France,
Berber E, Parikh RT, Ballem N, Garner CN, Milas M, Siperstein AE. Factors contributing to negative parathyroid localization: an analysis of 1000 patients. Surgery. 2008 Jul;144(1):74-9. doi: 10.1016/j.surg.2008.03.019. Epub 2008 May 21. — View Citation
Christou N, Mathonnet M. Complications after total thyroidectomy. J Visc Surg. 2013 Sep;150(4):249-56. doi: 10.1016/j.jviscsurg.2013.04.003. Epub 2013 Jun 6. — View Citation
Fabelo H, Ortega S, Ravi D, Kiran BR, Sosa C, Bulters D, Callico GM, Bulstrode H, Szolna A, Pineiro JF, Kabwama S, Madronal D, Lazcano R, J-O'Shanahan A, Bisshopp S, Hernandez M, Baez A, Yang GZ, Stanciulescu B, Salvador R, Juarez E, Sarmiento R. Spatio-spectral classification of hyperspectral images for brain cancer detection during surgical operations. PLoS One. 2018 Mar 19;13(3):e0193721. doi: 10.1371/journal.pone.0193721. eCollection 2018. — View Citation
Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31. — View Citation
Falco J, Dip F, Quadri P, de la Fuente M, Rosenthal R. Cutting Edge in Thyroid Surgery: Autofluorescence of Parathyroid Glands. J Am Coll Surg. 2016 Aug;223(2):374-80. doi: 10.1016/j.jamcollsurg.2016.04.049. Epub 2016 May 20. — View Citation
Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15. — View Citation
Kumashiro R, Konishi K, Chiba T, Akahoshi T, Nakamura S, Murata M, Tomikawa M, Matsumoto T, Maehara Y, Hashizume M. Integrated Endoscopic System Based on Optical Imaging and Hyperspectral Data Analysis for Colorectal Cancer Detection. Anticancer Res. 2016 Aug;36(8):3925-32. — View Citation
Li Q, He X, Wang Y, Liu H, Xu D, Guo F. Review of spectral imaging technology in biomedical engineering: achievements and challenges. J Biomed Opt. 2013 Oct;18(10):100901. doi: 10.1117/1.JBO.18.10.100901. — View Citation
Lu G, Fei B. Medical hyperspectral imaging: a review. J Biomed Opt. 2014 Jan;19(1):10901. doi: 10.1117/1.JBO.19.1.010901. — View Citation
Mohebati A, Shaha AR. Anatomy of thyroid and parathyroid glands and neurovascular relations. Clin Anat. 2012 Jan;25(1):19-31. doi: 10.1002/ca.21220. Epub 2011 Jul 28. — View Citation
Nair CG, Babu MJ, Menon R, Jacob P. Hypocalcaemia following total thyroidectomy: An analysis of 806 patients. Indian J Endocrinol Metab. 2013 Mar;17(2):298-303. doi: 10.4103/2230-8210.109718. — View Citation
Panasyuk SV, Yang S, Faller DV, Ngo D, Lew RA, Freeman JE, Rogers AE. Medical hyperspectral imaging to facilitate residual tumor identification during surgery. Cancer Biol Ther. 2007 Mar;6(3):439-46. doi: 10.4161/cbt.6.3.4018. Epub 2007 Mar 16. — View Citation
Schols RM, Alic L, Wieringa FP, Bouvy ND, Stassen LP. Towards automated spectroscopic tissue classification in thyroid and parathyroid surgery. Int J Med Robot. 2017 Mar;13(1). doi: 10.1002/rcs.1748. Epub 2016 May 19. — View Citation
Siddiqi AM, Li H, Faruque F, Williams W, Lai K, Hughson M, Bigler S, Beach J, Johnson W. Use of hyperspectral imaging to distinguish normal, precancerous, and cancerous cells. Cancer. 2008 Feb 25;114(1):13-21. doi: 10.1002/cncr.23286. — View Citation
Sumpio BJ, Citoni G, Chin JA, Sumpio BE. Use of hyperspectral imaging to assess endothelial dysfunction in peripheral arterial disease. J Vasc Surg. 2016 Oct;64(4):1066-73. doi: 10.1016/j.jvs.2016.03.463. Epub 2016 Jun 4. — View Citation
Yazici P, Bozkurt E, Citgez B, Kaya C, Mihmanli M, Uludag M. Incidental parathyroidectomy as a cause of postoperative hypocalcemia after thyroid surgery: reality or illusion? Minerva Chir. 2014 Dec;69(6):315-320. Epub 2014 Sep 22. — View Citation
Yudovsky D, Nouvong A, Pilon L. Hyperspectral imaging in diabetic foot wound care. J Diabetes Sci Technol. 2010 Sep 1;4(5):1099-113. doi: 10.1177/193229681000400508. — View Citation
Yudovsky D, Nouvong A, Schomacker K, Pilon L. Monitoring temporal development and healing of diabetic foot ulceration using hyperspectral imaging. J Biophotonics. 2011 Aug;4(7-8):565-76. doi: 10.1002/jbio.201000117. Epub 2011 Apr 1. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the intraoperative detection rate between the automated HSI-based parathyroid recognition against the surgeon's clinical appreciation. | 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. | 1 day | |
Primary | Comparison of the intraoperative detection rate between the Fluobeam®, against the surgeon's clinical appreciation. | 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. | 1 day | |
Secondary | in vivo collection of HSI spectral features of the parathyroid and thyroid glands to successively enable automated recognition. | Collection of clean and consistent datasets of the parathyroid and thyroid glands | 1 day | |
Secondary | 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. | Collection of clean and consistent datasets of other tissues exposed during neck surgery. The information will be implemented in the machine learning algorithm in order to allow in the future an automated recognition of the different target structures during neck surgery. | 1 day | |
Secondary | Recognition of possible pathology specific HSI spectral features of pathological parathyroid or thyroid glands. | The ability to predict pathological parathyroid or thyroid glands from the spectral tissue information, based on the final histopathological reports. | 1 month | |
Secondary | Difference in time to recognition between human eye, Fluobeam® and HSI | Comparison between the time of recognition using the HSI algorithm and the Fluobeam® | 1 day | |
Secondary | Detection rate of the recurrent laryngeal nerve against the clinical impression and the intraoperative neuromonitoring. | Number of times the recurrent laryngeal nerve is detected by the automated identification against the number of time it is visually identified by the operating surgeon and confirmed with the Intraoperative neuromonitoring (IONM). | 1 day |
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