Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 8:01 PM
Study NCT ID:
NCT01598727
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Near Infrared Fluorescent Imaging in Thyroid and Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Phase I Feasibility Study of Intra-operative Near Infra-red Fluorescent Imaging in Thyroid/Parathyroid Surgery With the Fluobeam(TM) System of Fluoptics
Status:
COMPLETED
Status Verified Date:
2013-08
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:
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.
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.
Detailed Description:
As above
Study Oversight
Has Oversight DMC:
True
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?: