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

Phase 1

Completed

• Conditions: Primary Hyperparathyroidism
• Interventions: Device: Fluobeam(TM) Imaging System (Fluoptics)

• Registration Number: NCT01598727
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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:

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.

Detailed Description

As above

Study Timeline

• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Study Start: 2012-07
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluobeam(TM) Imaging System (Fluoptics)	Fluobeam(TM) Imaging System (Fluoptics)	Single arm observational pilot study

Primary Outcome Measures

Name	Time	Method
Determine patterns of fluorescence from soft tissue structures in the neck	1 Day	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'.

Trial Locations

Locations (1)

Department of General Surgery; 🇬🇧 Sheffield, South Yorkshire, United Kingdom