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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03643081

Collaborator

(none)

132

Enrollment

Location

Arms

66.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Primary Hyperparathyroidism	Device: Use of the camera "Fluobeam"	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism. A Randomized Controled Prospective Open -Labeled Monocentric Study.

Actual Study Start Date :

Dec 20, 2018

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: use of camera "Fluobeam"	Device: Use of the camera "Fluobeam" Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.
No Intervention: Without use of the camera "Fluobeam"

Arm

Intervention/Treatment

Experimental: use of camera "Fluobeam"

Device: Use of the camera "Fluobeam"

Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.

No Intervention: Without use of the camera "Fluobeam"

Outcome Measures

Primary Outcome Measures

To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam". [At Day 1(parathyroidectomy)]

Secondary Outcome Measures

To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery. [At 6 months post parathyroïdectomy]
To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery determined by normocalcemia (2,20 mmol/L < calcium < 2,60 mmol/L) at 6 months post surgery.
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands. [At Day 1(parathyroidectomy)]
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of post-surgery laryngeal paralysis. [At 6 months post parathyroïdectomy]
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of parathyroid morbidity (hypocalcemia with calcémia below 2 mmol/L) [At 6 months post parathyroïdectomy]
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of cost-utility analysis according to the societal perspective and over a 6 months' time horizon of the surgery. [At 6 months post parathyroïdectomy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nantes	Nantes		France	44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: Eric MIRALLIE, Pr, CHU de Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT03643081

Other Study ID Numbers:

RC18_0260

First Posted:

Aug 22, 2018

Last Update Posted:

Dec 16, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperparathyroidism

Hyperparathyroidism, Primary

Study Results

No Results Posted as of Dec 16, 2020