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Precise Recognition With Enhanced Vision of Endocrine Neck Targets

NCT04745793 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2024-01-09

No results posted yet for this study

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

Interventions

OTHER

Hyperspectral and Fluobeam acquisition

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.

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Michele DIANA, MD, PhD · Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2021-10-15
Completion
2021-10-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745793 on ClinicalTrials.gov