Precise Recognition With Enhanced Vision of Endocrine Neck Targets

NCT04745793 | Terminated

• 1 other identifier: 20-007
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Diseases; Parathyroid Diseases

Keywords

Hyperspectral Imaging; Deep learning; Autonomous tissue recognition; Tissue spectral signature; Autofluorescence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• in vivo collection of HSI spectral features of the parathyroid and thyroid glands to successively enable automated recognition.

  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

• Recognition of possible pathology specific HSI spectral features of pathological parathyroid or thyroid glands.

  1 month

• Difference in time to recognition between human eye, Fluobeam® and HSI

  1 day

• Detection rate of the recurrent laryngeal nerve against the clinical impression and the intraoperative neuromonitoring.

  1 day

Study Arms (2)

Thyroids

The aim is to identify and preserve the parathyroid glands during the total or partial removal of the thyroid. Repeating of the procedure for each lobe

Other: Hyperspectral and Fluobeam acquisition

Parathyroids

The aim is to selectively remove the pathological parathyroid gland(s). Repeating of the procedure for each removed gland

Other: Hyperspectral and Fluobeam acquisition

Interventions

Hyperspectral and Fluobeam acquisition OTHER

Once enough exposure of the operative site is achieved, an RGB (Red Green Blue) picture will be taken and the surgeon will depict the parathyroid glands on it, this picture will act as "ground truth". At this point, without changing the surgical exposure, a second surgeon involved in the study will attempt once to detect the parathyroid glands intraoperatively using the HSI system and the Fluobeam® alternatively. The number and the position of the parathyroid glands visualized with each tool will be compared to the number and position of the glands previously visualized by the operating surgeon. The procedure will be repeated every time the surgeon attempts to visualize the parathyroid glands. The order of the detection tools randomized for each case will be preserved in case of repeated visualizations.

Parathyroids; Thyroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients of both sexes for whom a total or partial thyroid or parathyroid resection for a benign or malignant pathology is programmed

You may qualify if:

• 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.

You may not qualify if:

• Patient who needs an emergency surgery
• Pregnant or lactating patient.
• Patient under guardianship or trusteeship.
• Patient under the protection of justice.

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

Location

Related Publications (18)

• 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.

  PMID: 21800365 BACKGROUND

• 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.

  PMID: 23746996 BACKGROUND

• 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.

  PMID: 23776907 BACKGROUND

• 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.

  PMID: 25242004 BACKGROUND

• 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.

  PMID: 18571587 BACKGROUND

• 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.

  PMID: 28364157 BACKGROUND

• 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.

  PMID: 27212004 BACKGROUND

• 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.

  PMID: 24114019 BACKGROUND

• 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.

  PMID: 24441941 BACKGROUND

• 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.

  PMID: 18213691 BACKGROUND

• 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.

  PMID: 17374984 BACKGROUND

• 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.

  PMID: 27466495 BACKGROUND

• 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.

  PMID: 29554126 BACKGROUND

• 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.

  PMID: 27266597 BACKGROUND

• 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.

  PMID: 17303790 BACKGROUND

• 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.

  PMID: 20920429 BACKGROUND

• 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.

  PMID: 21462349 BACKGROUND

• 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.

  PMID: 27198506 BACKGROUND

Related Links

• Barberio et al. Hyperspectral based discrimination of thyroid and parathyroid during surgery. Current Directions in Biomedical Engineering (2018)4:399-402

MeSH Terms

Conditions

Thyroid Diseases; Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Michele DIANA, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: January 20, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)