Total Thyroidectomy Clinical Trial
Official title:
Development of a Clinical Protocol to Use Intra-operative Near Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
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.
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.
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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