NCT01598727

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Hyperparathyroidism

Interventions

Type	Name	Description
DEVICE	Fluobeam(TM) Imaging System (Fluoptics)	Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2012-05-15
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom