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NCT Number: NCT01598727

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

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.

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of General Surgery

Sheffield, South Yorkshire, S10 2JF, United Kingdom

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluobeam(TM) Imaging System (Fluoptics)

Device

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

Primary outcomes

  1. Determine patterns of fluorescence from soft tissue structures in the neck

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Fluoptics Ltd, Grenoble, France

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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