Near Infrared Fluorescent Imaging in Thyroid and Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
NCT ID: NCT01598727
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2012-07-31
2013-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fluobeam(TM) Imaging System (Fluoptics)
Single arm observational pilot study
Fluobeam(TM) Imaging System (Fluoptics)
Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery
Interventions
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Fluobeam(TM) Imaging System (Fluoptics)
Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fluoptics Ltd, Grenoble, France
UNKNOWN
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Saba P Balasubramanian, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sheffield
Locations
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Department of General Surgery
Sheffield, South Yorkshire, United Kingdom
Countries
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Other Identifiers
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STH16019
Identifier Type: -
Identifier Source: org_study_id