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

Primary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598727
• Other study ID #: STH16019
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2012
• Last updated: August 23, 2013
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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:

1. To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device (Fluoptics).

2. 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.

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

Device:
• Fluobeam(TM) Imaging System (Fluoptics)
Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery

Locations

Country	Name	City	State
United Kingdom	Department of General Surgery	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Fluoptics Ltd, Grenoble, France

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No