Near Infrared Fluorescent Imaging in Thyroid and Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Intraoperative use of near infrared fluorescent imaging technology and detection of Methylene Blue fluorescence will improve outcomes following thyroid and parathyroid surgery. Aims: The aims of this phase of the study are to determine the feasibility of using near infrared fluorescent technology in the detection of parathyroid tissue and its differentiation from adjacent soft tissue during surgery on parathyroid glands. Objectives of the phase I study: To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device (Fluoptics). To understand the patterns (onset, intensity and duration) of fluorescent staining of normal parathyroid glands, thyroid glands and other soft tissue structures encountered during parathyroidectomy. Further research: This will be followed by a phase II study during which fluorescent imaging will be used in conjunction with intraoperative incremental dose of IV methylene blue in both thyroid and parathyroid surgery. Phase II will enable us to develop a protocol for the use of a minimum possible dose of MB for the identification of parathyroid glands. This will then be tested in the pilot phase of a randomized clinical trial.

Detailed Description
-----------------
As above

Official Title
-----------------
A Phase I Feasibility Study of Intra-operative Near Infra-red Fluorescent Imaging in Thyroid/Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics

Conditions
-----------------
Primary Hyperparathyroidism

Intervention / Treatment
-----------------
* Device: Fluobeam(TM) Imaging System (Fluoptics)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing parathyroid surgery Exclusion Criteria: patients undergoing re-do procedures patients unable to give adequate informed consent patients with a history of intolerance or sensitivity to MB patients with G6PD deficiency patients on serotonin reuptake inhibitors and patients undergoing thoracic exploration either alone or in combination with a neck exploration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluobeam(TM) Imaging System (Fluoptics)<br>Single arm observational pilot study | Device: Fluobeam(TM) Imaging System (Fluoptics)<br>* Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine patterns of fluorescence from soft tissue structures in the neck | This is a proof of principle study aimed to demonstrate that the patterns of Methylene Blue emitted fluorescence from the parathyroid glands, thyroid glands and other soft tissue structures in the neck such as lymph glands are distinct and can be used to differentiate between them at surgery. The fluorescence from the various structures will be recorded as 'no', 'mild' and 'yes'. | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parathyroid surgery