Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02089542
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2014-03-13
Brief Title:
Intra-operative Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Development of a Clinical Protocol to Use Intra-operative Near Infra-red Fluorescent Imaging in Thyroid and Parathyroid Surgery
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 01mgkg 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
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 01mgkg 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 13000 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 andor 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 01mgkg 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
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 01mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None