Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    132
  • sponsor
    Nantes University Hospital
Updated on 27 January 2021

Summary

The aim of our study is to evaluate the value of the camera called "Fluobeam" in the localization, visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.

Description

Recently, it has been shown that parathyroid glands presented auto fluorescence, visible in the near infra-red light. Parathyroid glands emit at 822 nanometers when they are stimulated by a laser of 785 nanometers. Fluoptics Company (Fluoptics SAS, Grenoble, France) will provide a camera called "Fluobeam", facilitating the visualization of the parathyroid glands. The fluorescence intensity of the parathyroid glands is much more elevated than that of the surrounding tissues.

Preliminary work showed the interest of this technique. Benmiloud and collabortors have shown that the utilization of the "Fluobeam" enable to decrease the post total thyroidectomy hypocalcemia rate by a better visualization and preservation of the parathyroid glands.

The aim of this study is to evaluate the value of "Fluobeam" in the localization, visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.

Details
Condition Mild Primary Hyperparathyroidism
Treatment Use of the camera "Fluobeam"
Clinical Study IdentifierNCT03643081
SponsorNantes University Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult between 18 and 80 years old
Given signed written informed consent
Patient with moderated and sporadic primary hyperparathyroism (albumin-corrected serum calcium 2.85 mmol/l) requiring to be operated on
Patient affiliated to a social security system

Exclusion Criteria

Underage and adults under guardianship
Pregnant or breast feeding women
Patients with history of cervical radiotherapy or cervicotomy
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