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

NCT01598727 | Completed Phase 1 DMC

• 1 other identifier: STH16019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.To familiarise surgical teams with the intraoperative use of the 'Fluobeam(TM)' device (Fluoptics).
2. 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.

Conditions

Primary Hyperparathyroidism

Keywords

parathyroid surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fluobeam(TM) Imaging System (Fluoptics)

EXPERIMENTAL

Single arm observational pilot study

Device: Fluobeam(TM) Imaging System (Fluoptics)

Interventions

Fluobeam(TM) Imaging System (Fluoptics) DEVICE

Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery

Fluobeam(TM) Imaging System (Fluoptics)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients undergoing parathyroid surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Fluoptics Ltd, Grenoble, France: collaborator

Study Sites (1)

Department of General Surgery

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Saba P Balasubramanian, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 15, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

GB (1)