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

Primary Purpose

Total Thyroidectomy, Bilateral Neck Exploration for Primary Hyperparathyroidism

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MB and fluorescent imaging
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Thyroidectomy focused on measuring thyroidectomy, parathyroid surgery, parathyroid identification, methylene blue, near infrared fluorescence, intraoperative imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of General Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MB and fluorescent imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to peak fluorescence
Time to peak fluorescence at varying doses of Methylene Blue will be assessed during the observation period, which will be a maximum of twenty minutes.

Full Information

First Posted
March 13, 2014
Last Updated
November 1, 2016
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02089542
Brief Title
Intra-operative Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
Official Title
Development of a Clinical Protocol to Use Intra-operative Near Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Around 13,000 thyroid and parathyroid operations are performed per year in England for both benign and malignant disease. 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); the latter is associated with significant long term problems. 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. At these doses, there is a risk of adverse effects from administration of MB. Such visual examination is unhelpful in the identification of 'normal' parathyroid tissue. MB is not currently used in surgery for thyroid pathologies. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Thyroidectomy, Bilateral Neck Exploration for Primary Hyperparathyroidism
Keywords
thyroidectomy, parathyroid surgery, parathyroid identification, methylene blue, near infrared fluorescence, intraoperative imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MB and fluorescent imaging
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
MB and fluorescent imaging
Other Intervention Name(s)
Methylthioninium chloride, Fluobeam 700 near infra-red imaging device
Intervention Description
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
Primary Outcome Measure Information:
Title
Optimum dose of Methylene Blue
Description
Determine optimum dose of Methylene Blue that will enable fluorescence to be detected from the soft tissue structures in the neck
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Time to peak fluorescence
Description
Time to peak fluorescence at varying doses of Methylene Blue will be assessed during the observation period, which will be a maximum of twenty minutes.
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
Postoperative calcium status
Time Frame
up to 12 weeks of surgery
Title
Serious adverse event
Description
This will include any one of the following: Death A life-threatening adverse event Inpatient hospitalisation or prolongation of existing hospitalisation A disability / incapacity A congenital anomaly in the offspring of a participant The reporting period for Serious Adverse Events will be from the time of induction of anaesthetic until 30 days after the day of surgery. Important medical events that may not result in death, be life-threatening, or require hospitalisation may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. All adverse events will be assessed for seriousness, expectedness and causality.
Time Frame
up to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -All patients undergoing either a total thyroidectomy or bilateral neck exploration for PHPT in Sheffield Teaching Hospitals NHS Foundation Trust Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba Balasubramanian, MS FRCS PhD
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

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

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