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

NHS Foundation Trust

Status and phase: Completed; Phase 1

Conditions: Primary Hyperparathyroidism

Treatments: Device: Fluobeam(TM) Imaging System (Fluoptics)

Study type: Interventional

Funder types: Other

Identifiers

NCT01598727

STH16019

Details and patient eligibility

About

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.

Full description

As above

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Fluobeam(TM) Imaging System (Fluoptics)

Experimental group

Description:

Single arm observational pilot study

Treatment:

Device: Fluobeam(TM) Imaging System (Fluoptics)