Intra-operative Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery

NCT02089542 | Completed Phase 1 DMC

• 1 other identifier: STH17176
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Reliable identification of parathyroid glands is critical to the success of thyroid and parathyroid surgery. In thyroid surgery, inadvertent injury to parathyroid glands may cause temporary or permanent hypoparathyroidism (low calcium levels needing long term treatment). In parathyroid surgery, early identification of normal and/or enlarged parathyroid glands helps in deciding on the extent of surgery and increases the chances of postoperative normal calcium levels. Methylene Blue (Methylthioninium chloride, MB) is a dye that when given intravenously in high doses, is taken up differently by thyroid and parathyroid tissue. It is currently used during parathyroid surgery by some surgeons to help identify enlarged parathyroid glands by visual examination alone. Such visual examination is unhelpful in the identification of 'normal' parathyroid tissue. MB exhibits fluorescent properties in the near-infrared range (light just beyond the visible spectrum). This can be picked up by an appropriate imaging system. This has potential to identify and differentiate between 'normal' parathyroid, 'abnormal' parathyroid and thyroid tissue during surgery. The investigators have established the feasibility of the intra-operative use of a near infra-red fluorescent imaging device called Fluobeam® and demonstrated the ability of this device to pick up near infra-red fluorescence from human tissue after administration of intravenous MB. Animal experiments have shown that doses as low as 0.1mg/kg of MB given intravenously enable fluorescent visualisation of thyroid and parathyroid glands. This study will aim to optimise the dose and timing of administration of MB in human thyroid and parathyroid surgery and to develop a protocol which would then subsequently be assessed for effectiveness in a multi-centred randomized controlled setting.

Conditions

Total Thyroidectomy; Bilateral Neck Exploration for Primary Hyperparathyroidism

Keywords

thyroidectomy; parathyroid surgery; parathyroid identification; methylene blue; near infrared fluorescence; intraoperative imaging

Outcome Measures

Primary Outcomes (1)

• Optimum dose of Methylene Blue

  Determine optimum dose of Methylene Blue that will enable fluorescence to be detected from the soft tissue structures in the neck

  20 minutes

Secondary Outcomes (1)

• Time to peak fluorescence

  20 minutes

Other Outcomes (2)

• Postoperative calcium status

  up to 12 weeks of surgery

• Serious adverse event

  up to 30 days after surgery

Study Arms (1)

MB and fluorescent imaging

EXPERIMENTAL

Single arm study for the development of a protocol stipulating the optimum dose and time to peak near infra-red fluorescence from intraoperative injection of low dose Methylthioninium chloride

Other: MB and fluorescent imaging

Interventions

MB and fluorescent imaging OTHER

Single arm study for the development of a protocol stipulating the optimum dose and time to peak near infra-red fluorescence from intraoperative injection of low dose Methylthioninium chloride

Also known as: Methylthioninium chloride, Fluobeam 700 near infra-red imaging device

MB and fluorescent imaging

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 either a total thyroidectomy or bilateral neck exploration for PHPT in Sheffield Teaching Hospitals NHS Foundation Trust

You may not qualify if:

• Patients undergoing re-do procedures
• Patients unable to understand spoken and written English
• Patients unable to give adequate informed consent
• Patients with a history of intolerance or sensitivity to MB
• Patients with known G6PD deficiency
• Patients on serotonin reuptake inhibitors
• Patients undergoing surgery for thyroglossal cyst and
• Patients undergoing thoracic exploration; either alone or in combination with a neck exploration

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Department of General Surgery

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Saba Balasubramanian, MS FRCS 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: March 13, 2014
• First Posted: March 17, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)